Franck’s Pharmacy Closes; Compounding Lab is Now Wells Pharmacy Network

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

July 31, 2012, marked the end of an era for Franck’s Pharmacy in Ocala, Florida, as the retail location closed its doors for good. According to an Ocala Star-Banner article, in July 2012, Franck’s Compounding Lab, which was one of the largest compounding labs in the country, was bought by Wells Pharmacy Network. The deal included Franck’s Lifestyles, which sells supplements and wellness products, but did not include the retail pharmacy location.

Click here to see the official press release from Wells Pharmacy Network.

Closed Pharmacy Comes After a U.S. Food and Drug Administration (FDA) Finding of Fungal Growth in Pharmacy’s Clean Room.

In May of 2012, Franck’s Pharmacy Inc., issued a recall for its compounded prescriptions. The prescriptions impacted by this recall included all sterile human and veterinary compounded prescriptions distributed by Franck’s Pharmacy from November 21, 2011 to May 21, 2012. 

The recall was apparently prompted by an 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 recalled its sterile compounds to prevent any possible risk of infection.

To see the FDA recall, click here.

Eye Infection Outbreak Linked to Franck’s Pharmacy Products.

Franck’s Pharmacy ceased sterile compounding in its Ocala lab 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.

I previously blogged about this story, click here to read the entire post.

Franck’s Trouble in the Past.

According to the Ocala Star-Banner, the eye preparation case was the second time Franck’s faced claims of improper compounding. In 2009, Franck’s veterinary division allegedly improperly mixed a nutritional supplement for 21 polo horses that contained far more selenium than required. The horses all died.

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:

Medina, Carlos. “Franck’s Pharmacy Closes its Doors.” Ocala Star-Banner. (July 31, 2012). From: http://www.ocala.com/article/20120731/ARTICLES/120739961?p=3&tc=pg

Ulbricht, Christopher. “Wells Pharmacy Network Expands to Ocala, Florida.” Franck’s. (July 5, 2012.) From:  http://www.francks.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 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 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.

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.

Copyright © 1996-2012 The Health Law Firm. All rights reserved.

Meningitis Cases in Florida Continue to Rise – Doctors Getting Sued

10 Indest-2008-7By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

The Florida Department of Health (DOH) confirmed another case of fungal meningitis in Florida on November 19, 2012. A 56-year-old man allegedly received a contaminated steroid injection at Florida Pain Clinic in Marion County, Florida. This brings the state’s total number of fungal meningitis cases up to 24, including three deaths.

To read the entire press release from the Florida DOH, click here.

Meningitis Numbers Around the U.S. 

As of November 19, 2012, the Florida DOH reported the number of fungal meningitis cases nationwide is up to 480 with 33 deaths in 19 states.

The meningitis outbreak is reportedly linked to contaminated steroids made at the New England Compounding Center (NECC) in Framingham, Massachusetts, which is now closed. The compounding pharmacy was allegedly not following the requirements of its state license, according to the Massachusetts DOH. Under Massachusetts state law the NECC was only supposed to produce medications for patient-specific prescriptions, but it is believed the compounding pharmacy was preparing drugs in bulk. I previously wrote a blog on the reports related to the compounding pharmacy violating its license. Click here to read that blog.

Victims Sue Physicians.

Victims of the meningitis outbreak are starting to file lawsuits against the physicians and clinics that administered the tainted steroids. In a Business Insurance article released on October 28, 2012, I was quoted as saying liability might be established to the extent that the physicians were aware that the steroids distributed by the NECC violated regulations on compounding prescription medications. To read the entire article from Business Insurance, click here.

Florida and Fungal Outbreaks.

 Florida has seen its share of fungal outbreaks. I previously blogged about the problems encountered by Franck’s pharmacy in Ocala, Florida. It was 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.Jameson. Marni. “Florida Health Officials Confirm State’s 24th Case of Fungal Meningitis.” Orlando Sentinel. (November 19, 2012). From: ttp://www.orlandosentinel.com/news/local/breakingnews/os-florida-fungal-meningitis-20121119,0,3451600.story

Comments?

What do you think of the lawsuits again the physicians and clinics that administered the tainted steroid shots? Please leave any thoughtful comments below.

Sources:

Hiers, Fred. “Man Who Received Injection Locally Confirmed to Have Fungal Meningitis.” Ocala Star Banner. (November 19, 2012). From: http://www.ocala.com/article/20121119/ARTICLES/121119679/1412?Title=Man-who-received-injection-locally-confirmed-to-have-fungal-meningitis

Greenwald, Judy. “Meningitis Lawsuits Target Physicians.” Business Insurance. (October 28, 2012), From: http://www.businessinsurance.com/article/20121028/NEWS07/310289984?tags=|75|303

Hammonds, Jessica. “Florida Department of Health Uncovers Case of Fungal Meningitis.” Florida Department of Healht. (November 19, 2012). From: ttp://newsroom.doh.state.fl.us/wp-content/uploads/newsroom/2012/11/111912MeningitisUpdateonecase.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.

Copyright © 1996-2012 The Health Law Firm. All rights reserved.

Is It Legal to Make Flu Shots Mandatory for Health Care Professionals?

00011_RT8By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

The warnings have been loud and clear from the Centers for Disease Control and Prevention (CDC). This influenza season is off to an early and serious start. With that in mind, a number of states are requiring all health professionals in the state to receive the flu vaccination. Some of those opposed to getting vaccinated are being fired by hospitals and health facilities. Because of this, a controversy is arising between employee rights and patient safety, according to a number of news sources.

Click here to read more on this year’s flu season from the CDC.

Mandatory Flu Shots to Keep Patients Safe.

In December 2010, the Department of Health and Human Services (DHHS) announced a 10-year agenda to improve the nation’s health. It’s called Healthy People 2020. A part of this agenda calls for a ninety percent (90%) average vaccination rate of health professionals. Click here to read the press release on the Healthy People 2020 initiative from the DHHS.

According to an American Medical News article, there’s a push in the medical community to meet this goal as soon as possible. The CDC states that as of November 18, 2011, close to eighty-four percent (84%) of doctors in the U.S. had been immunized against influenza. The CDC is praising these doctors for this high number, hoping other health professionals and the public will follow suit.

The safety of patients is the chief reason for the mandate. In an ABC News article, one Indiana hospital said that it implemented the mandatory vaccine in September of 2012, to promote patient safety. Of the hospital’s 26,000 employees statewide, ninety-five percent (95%) have complied.

Health Care Professionals Are Fired If They Refuse to Get the Vaccine.

A large majority of employees at the Indiana hospital complied with the mandate; however, 1,300 employees did not. According to ABC News, eight employees, including at least three veteran nurses, were allegedly fired because they refused to get a flu vaccine.

The fired nurses are standing their ground, saying they should have the right to refuse the flu vaccine. One nurse had filed two medical exemption requests, a religious exemption request and two appeals. All were denied by the hospital. To read more on this story from ABC News, click here.

In October 2012, Rhode Island mandated immunizations for all health care workers who have patient contact. On December 6, 2012, a health care worker union filed a federal lawsuit against the Rhode Island Department of Health (DOH) to prevent it from implementing the regulations, according to a Fierce Healthcare article. Click here to read the entire Fierce Healthcare article.

Arguments Against the Flu Shot.

The attorney representing the Indiana nurses, who were fired, states that his clients had the right to refuse their flu shots. He argues Title VII of the Civil Rights Act of 1964 prohibits religious discrimination against employees. The attorney is suggesting religion is legally broad under the First Amendment, so it can include any strongly held belief. According to a Chicago Tribune article, in 2009 New York mandated flu shots for all health workers, during the H1N1 outbreak. Unions fought the issue in court, and the state has since relaxed the rule.

The Flu in Florida.

I’ve recently received calls from several local health care professionals working in different Florida hospitals, regarding refusing flu shots and other vaccinations. I’ve also read the news stories about Tampa General Hospital and Moffitt Cancer Center in Tampa requiring employees to receive the influenza vaccine. According to the news articles, the two Tampa health facilities require employees who refuse the flu shot to wear surgical masks.

However, the states and hospitals may not back down in this case. The issue may have to be decided by the courts. I promise to write more on this topic later.

Contact Health Law Attorneys Experienced in Representing Health Care Professionals and Providers.

At the Health Law Firm we provide legal services for all health care providers and professionals. This includes physicians, nurses, dentists, psychologists, psychiatrists, mental health counselors, Durable Medical Equipment suppliers, medical students and interns, hospitals, ambulatory surgical centers, pain management clinics, nursing homes, and any other health care provider. We represent facilities, individuals, groups and institutions in contracts, sales, mergers and acquisitions.

The services we provide include reviewing and negotiating contracts, business transactions, professional license defense, representation in investigations, credential defense, representation in peer review and clinical privileges hearings, Medicare and Medicaid audits, commercial litigation, and administrative hearings.

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 mandated flu shots for health care workers? Is receiving a flu shot mandatory at your job? As a health care professional, do you think it is important to receive a flu shot? Is there enough medical evidence to justify firing health care professionals for not receiving the flu shot? Please leave any thoughtful comments below.
Sources:

Lupkin, Sydney. “Nurses Fire for Refusing Flu Shot.” ABC News. (January 3, 2013). From: http://abcnews.go.com/Health/indiana-hospital-fires-nurses-refusing-flu-shot/story?id=18116967

Moyer, Christine. “More Physicians on Track to get Flu Shots.” American Medical News. (December 14, 2012). From: http://www.ama-assn.org/amednews/2012/12/10/hlsb1214.htm

Cheung-Larivee, Karen. “Health Unions Sue Over Mandated Flu Shots.” Fierce Healthcare. (December 10, 2012). From: http://www.fiercehealthcare.com/story/health-unions-sue-over-mandated-flu-shots/2012-12-10

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.

Two More Compounding Pharmacies Recall Drugs

CCS Blog LabelBy 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.

Negligence Will Determine the Success or Failure of the Meningitis Lawsuits Against Doctors and Clinics

6 Indest-2008-3By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

The victims and survivors of the meningitis outbreak are now filing lawsuits against the physicians and clinics that administered the tainted steroids. According to an article in The Tennessean, on January 29, 2013, a husband who lost his wife to fungal meningitis filed the first lawsuit against a Nashville outpatient clinic. It’s believed hundreds of people were injected at the same clinic with the tainted steroids. The man is now seeking $12.5 million in damages.

Click here to read the entire article from The Tennessean.

This lawsuit is just one in what is expected to be a series of lawsuits, in not just Tennessee, but across the country.

Compounding Pharmacy Allegedly Behind the Meningitis Outbreak is Out of Business.

The meningitis outbreak was at a peak in the fall of 2012. Contaminated steroid injections were allegedly made at the New England Compounding Center (NECC) in Framingham, Massachusetts. NECC is accused of shipping thousands of vials of tainted drugs across the country. There are allegedly 45 deaths nationwide from the steroids. The company shut down in October 2012, and filed for bankruptcy in December, according to an article in American Medical News.

Tennessee Complaint Alleges Outpatient Clinic Put Money Before Patients.

The man suing the Nashville outpatient clinic believes, among other things, that officials at the clinic put the company’s bottom line before patient care. The lawsuit specifically alleges:

1. The outpatient clinic ignored important information when it chose NECC to purchase thousands of vials of steroids,
2. That clinic officials failed to properly notify the victim that she had been injected with a potentially contaminated steroid,
3. That clinic officials failed to recommend the victim should receive treatment,
4. The clinic chose to purchase drugs from NECC because it was a cheaper than the safer alternatives.

Click here to read the entire complaint.

The Responsibility of Doctors and Clinics.

Negligence is the most common claim used against doctors in cases of defective medication. The assumption is that the physician breached the standard of care because he or she knew or should have known that NECC was not meeting applicable standards in compounding the medications. Another legal theory is that the physician should have known that certain medications should not have been compounded, but rather obtained directly from a manufacturer. I believe the liability of physicians and clinics might be established to the extent that the physicians were aware that the steroids distributed by NECC violated regulations on compounding prescription medications.

It’s imperative physicians and clinics are sure of the credentials of all vendors and suppliers.

I was recently quoted in an American Medical News article about physicians and clinics that are entangled in tainted drugs lawsuits. To read the entire article, click here.

Florida Compounding Pharmacy No Stranger to Fungal Outbreaks.

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

Pharmacists Need to Obtain Good Professional Liability Insurance.

Many pharmacists, especially those who work for state agencies, large hospitals, pharmacy chains or other large institutions, scrimp on their purchase of professional liability insurance. Many mistakenly believe their employer will cover any legal defense expenses. This is not true and is often found out too late.

A pharmacist should always carry his/her own professional negligence insurance. It is inexpensive and can cover many types of legal actions other than just civil negligence cases. Always, always, always be sure your insurance includes at least $25,000 in professional license defense coverage. Get this in writing!

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 about the lawsuits against these doctors and clinics? Who do you think should be help responsible: the compounding pharmacy that shipped the contaminated steroids, or the doctors and clinics that administered the steroid shots? Please leave any thoughtful comments below.

Sources:

Roche Jr., Walter. “Meningitis Outbreak: Victim’s Husband Sues Saint Thomas Clinic.” The Tennessean. (January 31, 2013). From: http://www.tennessean.com/apps/pbcs.dll/article?AID=2013301300211&nclick_check=1

Wayne A. Reed v. Saint Thomas Outpatient Neurosurgical Center. Case Number 13C-417. Complaint. (January 29, 2013). From: http://www.thehealthlawfirm.com/uploads/Reed%20v.%20St.%20Thomas%20Outpatient.pdf

Gallegos, Alicia. “Physicians Entangled in Tainted Drugs Lawsuits.” American Medical News. (February 11, 2013). From: http://www.thehealthlawfirm.com/uploads/AMN_PhysicianLawsuits.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.

Copyright © 1996-2012 The Health Law Firm. All rights reserved.

Indiana Nurses Fired for Refusing to Get Flu Shots

George F. Indest III is Board Certified by The Florida Bar in Health Law

George F. Indest III is Board Certified by The Florida Bar in Health Law

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

The warnings have been loud and clear from the Centers for Disease Control and Prevention (CDC). This influenza season is off to an early and serious start. With that in mind, a number of states are requiring all health professionals in the state to receive the flu vaccination. Some of those opposed to getting vaccinated are being fired by hospitals and health facilities. Because of this, a controversy is arising between employee rights and patient safety, according to a number of news sources.

Click here to read more on this year’s flu season from the CDC.

Agenda Calls for a 90% Average Vaccination Rate of Health Professionals by 2020.

In December 2010, the Department of Health and Human Services (DHHS) announced a 10-year agenda to improve the nation’s health. It’s called Healthy People 2020. A part of this agenda calls for a ninety percent (90%) average vaccination rate of health professionals. Click here to read the press release on the Healthy People 2020 initiative from the DHHS.

According to an American Medical News article, there’s a push in the medical community to meet this goal as soon as possible. The CDC states that as of November 18, 2011, close to eighty-four percent (84%) of doctors in the U.S. had been immunized against influenza. The CDC is praising these doctors for this high number, hoping other health professionals and the public will follow suit.

The safety of patients is the chief reason for the mandate. In an ABC News article, one Indiana hospital said that it implemented the mandatory vaccine in September of 2012, to promote patient safety. Of the hospital’s 26,000 employees statewide, ninety-five percent (95%) have complied.

Two Indiana Nurses and Others Fired for Not Getting Vaccinated.

A large majority of employees at the Indiana hospital complied with the mandate; however, 1,300 employees did not. According to ABC News, eight employees, including at least three veteran nurses, were allegedly fired because they refused to get a flu vaccine.

The fired nurses are standing their ground, saying they should have the right to refuse the flu vaccine. One nurse had filed two medical exemption requests, a religious exemption request and two appeals. All were denied by the hospital. To read more on this story from ABC News, click here.

In October 2012, Rhode Island mandated immunizations for all health care workers who have patient contact. On December 6, 2012, a health care worker union filed a federal lawsuit against the Rhode Island Department of Health (DOH) to prevent it from implementing the regulations, according to a Fierce Healthcare article. Click here to read the entire Fierce Healthcare article.

Fighting the Mandate.

The attorney representing the Indiana nurses, who were fired, states that his clients had the right to refuse their flu shots. He argues Title VII of the Civil Rights Act of 1964 prohibits religious discrimination against employees. The attorney is suggesting religion is legally broad under the First Amendment, so it can include any strongly held belief. According to a Chicago Tribune article, in 2009 New York mandated flu shots for all health workers, during the H1N1 outbreak. Unions fought the issue in court, and the state has since relaxed the rule.

Florida Health Care Professionals Worried About Jobs.

I’ve recently received calls from several local health care professionals working in different Florida hospitals, regarding refusing flu shots and other vaccinations. I’ve also read the news stories about Tampa General Hospital and Moffitt Cancer Center in Tampa requiring employees to receive the influenza vaccine. According to the news articles, the two Tampa health facilities require employees who refuse the flu shot to wear surgical masks.

However, the states and hospitals may not back down in this case. The issue may have to be decided by the courts. I promise to write more on this topic later.

Contact Health Law Attorneys Experienced in Representing Health Care Professionals and Providers.

At the Health Law Firm we provide legal services for all health care providers and professionals. This includes physicians, nurses, dentists, psychologists, psychiatrists, mental health counselors, Durable Medical Equipment suppliers, medical students and interns, hospitals, ambulatory surgical centers, pain management clinics, nursing homes, and any other health care provider. We represent facilities, individuals, groups and institutions in contracts, sales, mergers and acquisitions.

The services we provide include reviewing and negotiating contracts, business transactions, professional license defense, representation in investigations, credential defense, representation in peer review and clinical privileges hearings, Medicare and Medicaid audits, commercial litigation, and administrative hearings.

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

Sound Off.

What do you think of mandated flu shots for health care workers? Is receiving a flu shot mandatory at your job? As a health care professional, do you think it is important to receive a flu shot? Is there enough medical evidence to justify firing health care professionals for not receiving the flu shot? Please leave any thoughtful comments below.

Sources:

Lupkin, Sydney. “Nurses Fire for Refusing Flu Shot.” ABC News. (January 3, 2013). From: http://abcnews.go.com/Health/indiana-hospital-fires-nurses-refusing-flu-shot/story?id=18116967

Moyer, Christine. “More Physicians on Track to get Flu Shots.” American Medical News. (December 14, 2012). From: http://www.ama-assn.org/amednews/2012/12/10/hlsb1214.htm

Cheung-Larivee, Karen. “Health Unions Sue Over Mandated Flu Shots.” Fierce Healthcare. (December 10, 2012). From: http://www.fiercehealthcare.com/story/health-unions-sue-over-mandated-flu-shots/2012-12-10

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.

More Than 7,000 Patients of Oklahoma Dentist Are Being Asked to Get Tested for HIV and Hepatitis

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

The unsanitary practices of an Oklahoma dentist may have exposed more than 7,000 patients to HIV and hepatitis, according to a number of media sources and the Oklahoma Department of Health (DOH). Currently officials with the Oklahoma DOH are contacting all of the dentist’s patients since 2007, and urging them to get tested for blood-borne diseases. Since the news broke on March 28, 2013, the dentist has voluntarily closed his two offices and surrendered his dental license for 30 days.

Click here to read a copy of the letter from Oklahoma DOH warning the dentist’s patients to get tested.

We want to point out that these are just allegations made against the dentist at this point in time and have not been proven by the state.

Dentist Accused of Being a “Menace to the Public” in Complaint.

According to the complaint filed with the Oklahoma Board of Dentistry, the dentist is allegedly facing 17 allegations from The Board due to the violations against his practice.

Alleged charges against the dentist include:

1.  A patient testing positive for HIV and hepatitis C;

2.  The dental practice being unsafe, unsanitary and lacking of sterilization checks;

3.  Committing gross negligence related to decisions related to the dental health care of patients;

4.  Practicing dentistry without the proper display of licenses and certifications;

5.  Violation of provisions of the State Dental Practice Act by failing to keep a suitable record of dangerous drugs;

6.  Unlawful practices in authorizing dental assistants to practice dentistry; and

7.  Having open vials of medications and unsanitary dental materials in an unclean environment.

Click here to read the complaint.

Dentist Admitted to Not Handling Sterilization and Drugs Procedures.

According to the complaint, a device in the dentist’s office used to sterilize dental instruments wasn’t working properly. An inspector also found two separate sets of instruments. Each set was cleaned differently, one set of instruments was for patients known to have infectious diseases, and one set was for those not believed to have such diseases. Oklahoma DOH officials said the proper approach is for all instruments to be handled as if they contain viruses and infectious diseases.

According to an article in The New York Times, the dentist allegedly told officials during one inspection of his office that his staff handled all sterilization and drug procedures. Click here to read the entire article from The New York Times.

Dentist Faces Hearing at State Board of Dentistry.

According to the Oklahoma DOH, the dentist has been a state-licensed dentist since 1974, and an oral surgeon since 1977. He faces the possibility of having his license revoked, after a hearing on April 19, 2013, at the state Board of Dentistry in Oklahoma. This investigation is ongoing.

Contact Health Law Attorneys Experienced with Department of Health Investigations of Dentists.

The attorneys of The Health Law Firm provide legal representation to dentists in Department of Health (DOH) investigations, Drug Enforcement Administration (DEA) investigations, FBI 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 http://www.TheHealthLawFirm.com.

Comments?

What do you think of this dentist’s story? Are you curious as to how the practice got so bad? Please leave any thoughtful comments below.

Sources:

Oklahoma Board of Dentistry State of Oklahoma v. Wayne Scott Harrington, D.M.D. Case Number 13-005. Statement of Complaint. (March 28, 2013). From: http://www.thehealthlawfirm.com/uploads/OK%20Dentist%20Complaint.pdf

Ball, Brandi. “Tulsa County Dentist May Have Exposed 7,000 Patients to HIV, Hepatitis.” News on 6. (March 28, 2013). From: http://www.newson6.com/story/21820518/tulsa-county-dentist-may-have-exposed-patients-to-hiv-hepatitis

Oklahoma State Department of Health. “Tulsa Health Department, Oklahoma State Department of Health and Oklahoma Board of Dentistry Investigate Tulsa Dentist.” (March 28, 2013). From: http://bit.ly/ZwRhRT

Fernandez, Manny. “Tests Start for Patients of Dentist in Inquiry.” The New York Times. (March 29, 2013). From: http://www.nytimes.com/2013/03/30/health/dental-patients-in-oklahoma-warned-of-disease-risk.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.

Florida Department of Health (DOH) Shuts Down Boca Raton Compounding Pharmacy

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.

State Inspector Finds Feces, Bugs and Much More in 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.

Compounding Pharmacy Can Have a Hearing Before Action is Taken.

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.

Read About Another Florida Compounding Pharmacy Accused of Distributing Medications with Fungal Infection.

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.

Copyright © 1996-2012 The Health Law Firm. All rights reserved.

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