Walgreens Files a Petition to Lift the Immediate Suspension Order

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

There’s a firefight brewing between Walgreens and the Drug Enforcement Administration (DEA). On October 10, 2012, Walgreens filed a petition asking a federal judge to lift the Immediate Suspension Order (ISO) that bans its distribution center in Jupiter, Florida, from shipping controlled substances to its stores in Florida and on the East Coast.

Back on September 14, 2012, the DEA issued an ISO on the distribution center, calling it an “imminent danger” to the public. Click here to read a blog I previously wrote when the DEA issued the ISO.

Walgreens Claims the DEA Ignored Relevant Information.

In its petition, Walgreens claims the DEA ignored and “conspicuously omitted” recent and relevant information in its ISO. The pharmacy said it took voluntary steps designed to address concerns about the number of new prescriptions for controlled substances presented by pain clinic patients. Earlier this year the company also voluntarily stopped selling all Schedule II drugs, including OxyContin, at eight pharmacies that were of concern to the DEA and that were serviced by the Jupiter distribution center. Walgreens claims as a result of these efforts, the number of oxycodone pills and pain clinic prescriptions filled in recent months is an extremely small percent of the 2011 numbers, on which DEA relied upon to issue the ISO.

Walgreens is asking the federal appeals court to clear the ISO against the distribution center.

To see the Orlando Sentinel article, click here.

 

Numbers Released for Mean Nothing.

In an earlier blog I wrote that according to the DEA, six of Walgreens’ Florida pharmacies allegedly ordered more than a million oxycodone pills a year. That number might seem big at first, but after breaking it down, it’s actually not all that scary. You have to remember that Walgreens is the biggest pharmacy retailer in Florida.

For example, if a doctor issues 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 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 such statistics are meaningless out of context and are only meant to sound huge if one doesn’t stop and think about it.

Click here to see the press release from the DEA with the number of oxycodone pills purchased by store.

 

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 the appeal? Should the DEA have taken this action against Walgreens? Please leave any thoughtful comments below.

 

Source:

Pavul, Amy. “Walgreens Fights Back Against DEA, Wants Ban at Florida Distribution Center Lifted.” Orlando Sentinel. (October 11, 2012). From: ttp://www.orlandosentinel.com/news/local/breakingnews/os-walgreens-dea-oxycodone-20121011,0,1860346.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. 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.

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

Shortage of Florida Physicians Approved to Recommend “Green Leaf Relief” for Patients

George F. Indest III, 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

Florida may be “going green” in a big way come November 2016; and I’m not talking about recycling.  The Florida Right to Medical Marijuana Initiative, or Ballot Initiative Amendment 2, has undergone revisions, and will likely be making its second run with voters since its marginal loss in 2014.  Promoters of the Constitutional Amendment predict success; hopefully this isn’t just a pipe dream.

However, the Florida Compassionate Medical Cannabis Act of 2014, currently allows low-THC cannabis to be utilized only by qualifying patients for certain medical ailments.  A licensed physician, as outlined in Chapter 458 or 459 of Florida Statutes, is required to qualify patients for the use of medical marijuana.

For FAQ’s on low-THC cannabis issued by the Florida Department of Health (DOH), click here.

Physician Requirements for Qualifying Patients and Ordering.

For a patient to qualify to obtain and use THC, a previously approved physician must examine and currently be treating a patient for a debilitating illness.  Such illnesses include cancer or any physical medical condition or ailment that produces chronic seizures or severe and persistent muscle spasms (such as epilepsy or multiple sclerosis).  Furthermore, the physician must have tried all other options of treatment without satisfactory results.  Medical marijuana must be a last resort alternative.  Section 381.986(2), Florida Statutes (2015).

One of the physician ordering requirements is that the doctor must “register as the orderer of low-THC cannabis for the named patient on the compassionate use registry maintained by the department [of health] and update the registry to reflect the contents of the order.”  Section 381.986(2)(c), Florida Statutes (2015).

In order to become registered in Florida, licensed physicians must successfully complete an 8-hour course, offered by either the Florida Medical Association (FMA) or the Florida Osteopathic Medical Association (FOMA).  It is necessary for the physician to satisfactorily pass an examination upon completion of the course.  Section 381.986(4), Florida Statutes (2015).

Currently, only 42 doctors varied throughout Florida in areas to include Orlando, Pensacola, Tallahassee and Jacksonville, have signed up for authorization.

Why the Lack of Physicians?

Several theories may account for the lack of physician involvement in the program in Florida.

One of the theories that may explain why physicians are hesitant to jump on board with this new-age line of treatment, is the lack of scientific research conducted in the United States to back the medical efficacy of medical marijuana.  Scientists are reluctant to answer even the most basic questions about the use of medical marijuana including the long-term risks, actual benefits and the overall effect of legalization.

Many physicians may be concerned that the use of medical marijuana is supported more by popular opinion than on actual medical research.

However, a primary reason for insignificant research may be due to the unavailability of the drug for scientific study due to its illegal status.  The federal government entirely restricts the authorization to use marijuana for medical research.  The media is replete with stories on this.  As the debate over marijuana and its legalization for medical use becomes more widespread and pertinent, the drug has concurrently become more available for research.

For more information on current medical marijuana research efforts as reported by U.S.A. Today, click here.

Who Will Dispense the Marijuana?

Another hold-up in support from physicians may be due to the fact that the Department of Health (DOH) is still in the process of selecting the five dispensing organizations throughout Florida that will be developing and dispensing the drug.

As originally proposed, this requires an arduous application process presently consisting of proposals from 24 competing companies.  A dispensing organization must have the ability to meet several requirements as set forth in the statues, including the financial ability to post a $5 million performance bond upon approval.  Section 381.986(5)(b), Florida Statutes (2015).

Many physicians are still waiting to know where the drugs will be dispensed, what the dosages will be, what forms they will be available in and how much they will cost.  These are all important factors to consider in determining whether or not medical marijuana may be beneficial to certain patients.

Penalties for Misuse.

A final reason for physician avoidance of marijuana is fear of criminal prosecution and discipline by their boards, given the lingering gray areas of the law.

To read one of our previous blogs regarding a federal judge’s challenge of the DOJ’s incorrect interpretation of federal law on medical marijuana prosecutions and a win for medical marijuana advocates across the nation, click here.

It is undisputed that the use of medical marijuana is on the rise.  Therefore, any licensed physician who is contemplating or has already signed up for the program, needs to be sure they are in strict compliance with Florida law.

A physician is committing a misdemeanor, which may result in criminal penalties, if he or she orders low-THC cannabis for a patient without possessing a reasonable belief that the patient is suffering from one of the debilitating medical conditions as described in Section 381.986(3)(a)(1) and (2), Florida Statutes.

It is one of the ongoing duties of the dispensing organizations established by the Department to “monitor physician registration and ordering of low-THC cannabis for ordering practices that could facilitate unlawful diversion or misuse of low-THC cannabis and take disciplinary action as indicated.”  Section 381.986(5)(b)(7)(c), Florida Statutes (2015).

Therefore, a physician interested in obtaining authorization to order medical marijuana for his or her patients, should contact an experienced health attorney as a safeguard to ensure he or she complies fully with the law.

Comments?

Why do you believe there is a lack of physician involvement in Florida in the medical marijuana program?  What are your thoughts on the availability of medical marijuana in Florida?

Contact Experienced Health Law Attorneys for Medical Marijuana Concerns.

The Health Law Firm attorneys can assist health care providers and facilities, such as doctors, pharmacists and pharmacies, wanting to participate in the medical marijuana industry. We can properly draft and complete the applications for registration, permitting and/or licensing, while complying with Florida law. We can also represent doctors, pharmacies and pharmacists facing proceedings brought by state regulators or agencies.

To contact The Health Law Firm please call (407) 331-6620 and visit our website at 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 the Orlando, Florida, area.  www.TheHealthLawFirm.com  The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone:  (407) 331-6620.

Sources:

Powers, Scott.  “Medical-pot backers unfazed only 42 doctors in program.”  Orlando Sentinel 20 August 2015: Final.  Print.

Caputo, Mark.  “Medical marijuana supporters unveil new proposal for 2016.”  Miami Herald.  8 January 2015.  Web.  27 August 2015.

Keywords: medical marijuana lawyer, marijuana attorney, low-THC cannabis, medical cannabis, complaint against physician, Florida law, health attorney, doctor defense attorney Department of Health, Compassionate Medical Cannabis Act, disciplinary action for prescribing, medical marijuana regulations, prescribing controlled substances, physicians recommending marijuana, health regulation lawyer, medical license defense attorney, The Health Law Firm, health law attorney, DEA defense lawyer, medical marijuana ordering physician, compassionate-use in Florida, physician certifications for medical marijuana, cannabis for treatment of debilitating medical condition

“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 © 2017 The Health Law Firm. All rights reserved.

Drug Enforcement Administration (DEA) Investigates Six Walgreens Pharmacies in Florida

5 Indest-2008-2By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

The Drug Enforcement Administration (DEA) served an Order to Show Cause (OSC) on a Fort Myers Walgreens pharmacy on February 21, 2013. According to the DEA, the OSC was served as a notice to provide Walgreens with an opportunity to show cause as to why their DEA registration should not be revoked. The Fort Myers pharmacy is one of six Walgreens pharmacies to be targeted for prescribing practices by the DEA.

Click here to read the press release from the DEA.

According to the DEA, these investigations are part of an effort to curb Florida’s prescription drug epidemic.

Six Walgreens Pharmacies and One Distribution Center Targeted by DEA.

In April 2012, the DEA served and Administrative Inspection Warrant (AIW) on the Fort Myers Walgreens pharmacy, as well as five other Walgreens pharmacies in Florida and its distribution center in Jupiter. According to the DEA, the AIWs were served to determine if the pharmacies were dispensing prescriptions for legitimate medical purposes.

Based on the DEA’s findings, the Walgreens distribution center was served with an immediate suspension order (ISO). Click here to read our previous blog on the ISO served on the distribution center.

Between November 2012 and February 2013, the DEA has served OSCs on six Florida Walgreens pharmacies.

According to an article in Naples News, no action has been taken against the stores’ licenses, so they are still able to fill prescriptions pain medications and controlled substances. An administrative hearing will be held in April 2013. The hearing is an opportunity for Walgreens to present their cases. To read the entire Naples News article, click here.

Two CVS Stores in Sanford, Florida Lost Controlled Substance Licenses.

In September 2012, 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.

The Ultimate Results of Such Crackdowns.
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.

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 these investigations on big pharmacies? Please leave any thoughtful comments below.

Sources:

Drug Enforcement Administration. “DEA Serves an Order to Show Cause on Walgreen’s Pharmacy in Fort Myers.” Drug Enforcement Administration. (February 22, 2013). From: http://www.justice.gov/dea/divisions/mia/2013/mia022213a.shtml

Freeman, Liz. “DEA Targets Fort Myers Walgreens, 5 Other State Stores.” Naples News. (March 7, 2013). From: http://www.naplesnews.com/news/2013/mar/07/dea-targets-fort-myers-walgreens-5-other-state/?print=1

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

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