avilez- fl anti pill mill

Running head: FLORIDA ANTI-PILL MILL LEGISLATION AND CRACKDOWN 1

Florida Anti-Pill Mill Legislation and Crackdown

©2015 Nathaly Avilez

Florida International University

BUL6810: Legal Environment of Business

March 27, 2015

FLORIDA ANTI-PILL MILL LEGISLATION AND CRACKDOWN 2

The state of Florida has had an infamous reputation for its notorious history involving

cartels, the illegal drug trade, and violence that terrified a nation during the eighties. It was not

until a decade ago that Florida, once again, emerged into the spotlight as the nation’s “ground

zero” for having unregulated access for controlled substances. This unregulated access resulted

in the operation of a vast number of pain management clinics across Florida that were not only

being used as illegal dispensaries for controlled substances, but also weakened Florida’s

communities by struggling with its battle against prescription drug abuse. Florida Statutes have

been in place to fight drug abuse and prevention control, but Florida’s lax oversight of

prescription controlled substances triggered a statewide criminal scheme involving consumers

and healthcare providers. The pill mill crisis prompted Florida legislators to come up with a

solution to crackdown, regulate, and track the distribution of controlled substances in Florida

communities. The introduction of E-FORSCE has proven to be an effective strategy to combat

the Florida pill mill crisis, and it has encouraged the adoption of such programs across the nation.

A mandate is needed to make these guidelines within the programs a mandatory requirement for

all healthcare providers within the United States to effectively crackdown on the prescription

drug abuse in US communities, and persecute those who violate the law.

Pill Mills


The concept of a pill mill is really quite simple to understand. Attorney Ashley Dutko

(2010) depicts the following type of mill scenario. Patient X goes to Pain Clinic A complaining

of shoulder pain. The physician writes a prescription, and Patient X leaves the clinic. Within

moments Patient X walks into Clinic B complaining of the same pain as he reported in Clinic A.

He is then given a second prescription, and proceeds in filling his two prescriptions at two

different pharmacies. After prescriptions have been filled by “pharmacies” Patient X takes his

pain medications to Clinic C, which is owned by an individual with no medical expertise,

background, and a criminal record. This individual then buys Patient X’s pain medications that

were filled earlier in the day to then sell them for cash profit. In a second scenario, Patient X

visits Clinic C to obtain prescription drugs without the need of a medical examination or

physician written prescription.

These dispensaries are known as pill mills and “at these pill mills, doctors-“dispensing

practitioner”- have special authority to dispense the controlled substance directly to the patients,

without any pharmacist intervention” (Dutko, 2010, p.744). The DEA launched Operation Pill

Nation in 2011 to start the crackdown on Florida’s pill mill crisis (DEA, 2014). The arrests

would stem from undercover sting operations that would target physicians and also those

individuals involved in these criminal activities.

Criminal Offense


The dispensing of controlled prescription drugs outside the scope of legitimate medical

practice is considered a criminal offense, and is in violation of both, Florida Statutes and the

United States Code. These statutes outline specific laws to ensure the safety and proper handling

of dangerous prescription drugs that can be harmful to health. The United States Code clearly

mentions its findings, provisions, offenses, and penalties under title 21, Food & Drugs, chapter

13, Drug Abuse Prevention & Control. Moreover, the Florida Statutes under chapter 893, Drug

Abuse Prevention and Control, as well, identify these criminal offenses along with the penalties

under Florida law. The misuse of controlled substances by consumers and providers contributed

to the pill mill crisis. Unfortunately, even though statutes were in effect, the lax oversight of

controlled substances provided a gateway for easy access to unlicensed individuals, and those

with no medical necessity for them.

Florida Statute Title XLVI Chapter 893

According to the Florida Statute Title XLVI Chapter 893, Drug Abuse Prevention and

Controls, a controlled substance is defined as any substance named or described in Schedules I-V

of section 893.03. This chapter provides an overview of the laws in place to regulate the

manufacture, distribution, preparation, dispensing, and administration of these substances.

Section 893.03 identifies those controlled substances and classifies them in Schedules I-V. The

classification is based on their acceptance of medical treatments, their potential for abuse, and

the probability to cause dependency upon abuse.


Section 893.04 dictates the conditions needed when pharmacists and practitioners

dispense medications in good faith, and in the course of professional practice. More specifically,

section 893.04 (2)(e) indicates that a pharmacist may not dispense more than a 30 days supply of

a controlled substance listed in Schedule III. Section 893.04 (7)(g) states that a prescription for a

controlled substance may not be filled or refilled more than 5 times within a 6-month period.

Section 893.05 refers to those practitioners and individuals administering the controlled

substances in their absence; “A practitioner, in good faith and in the course of his or her

professional practice only, may prescribe, administer, dispense, mix, or other wise prepare a

controlled substance”. More specifically, 893.05 (2)(e), states that it is a crime to dispense

controlled substances to anyone other than the patient for whom it was prescribed for.

Furthermore, the section proceeds in specifying several other aspects of labeling such as

including dates, addresses, names, and directions for use.

Section 893.055 calls for a prescription drug monitoring program to enable the tracking

of all controlled substance prescriptions; “The department shall design and establish a

comprehensive electronic database system that has controlled substance prescriptions provided to

it and that provides prescription information to a patient’s health care practitioner and pharmacist

who inform the department that they wish the patient advisory report provided to them”. For

every prescription that is filled through a pharmacy or clinic, the provider has an obligation to

report that claim through the system with specific information required by the department such

as prescribing doctor information, prescriber’s DEA registration number, date it was filled, form

of payment, credit card information, and other specific information to help track the controlled

substance. The system serves as a centralized database where pharmacies and prescribers have

access to view a patient’s controlled substance prescription history.


Section 893.13 specifies prohibited acts and penalties under the law. This section

(893.13) clearly states that an individual may not sell, manufacture, deliver, or possess with the

intent to sell, manufacture, or deliver a controlled substance, as it also specifies the penalties

applied for specific acts. For instance, section 893.13 (6)(a) indicates that if a person is in

possession of a controlled substance that was unlawfully obtained, that person has committed a

felony of the third degree.

A person may not be in actual or constructive possession of a controlled substance unless such controlled substance was lawfully obtained from a practitioner or pursuant to a valid prescription or order of a practitioner while acting in the course of his or her professional practice or to be in actual or constructive possession of a controlled substance except as otherwise authorized by this chapter. A person who violates this provision commits a felony of the third degree…(s.893.13, 6, a).

Furthermore, section 893.13 (8) indicates that it is against the law for an individual to lie to a

healthcare provider, whom he or she is trying to acquire a prescription form from, about them

having received another prescription for a controlled substance from another provider during the

past 30 days. It also specifies the prohibited acts by practitioners such as prescribing controlled

substances without a real medical “necessity” 893.13 (13)(a), knowingly assisting patients in

obtaining controlled substances through false representations 893.13 (9)(1), and employing a

scheme to assist patients on obtaining such drugs 893.13 (9)(2).

Moreover, section 893.1351 sheds light into the ownership, lease, rental, or possession

for trafficking in or manufacturing a controlled substance. Section 893.1351 (1) states:

A person may not own, lease, or rent any place, structure, or part thereof, trailer, or other conveyance with the knowledge that the place, structure, trailer, or conveyance will be used for the purpose of trafficking in a controlled substance, as provided in s. 893.135; for the sale of a controlled substance, as provided in s. 893.13; or for the manufacture of a controlled substance intended for sale or

http://leg.state.fl.us/statutes/index.cfm?App_mode=Display_Statute&Search_String=&URL=0800-0899/0893/Sections/0893.13.html



distribution to another. A person who violates this subsection commits a felony of the third degree, punishable as provided in s. 775.082, s. 775.083, or s. 775.084.

Florida Faux Pa Leads to New Legislation

With these statutes in place one can only query where the faux pa occurred that resulted

in the pill mill crisis. According to Dutko (2010), before 2009 Florida was one of the twelve

states in the nation that lacked a prescription drug-monitoring database. Because of this, there

was no way to track prescriptions for controlled substances; prescriptions could have been filled

whenever, wherever, and as many times as someone wanted. In June 2009, the Florida senate

passed a new legislature that called for a mandatory prescription drug-monitoring database,

Senate Bill 462, which was signed by Florida Governor, Charlie Crist, on June 18, 2009. The bill

created section 893.055 under chapter 893 in the title XLVI of the Florida Statutes which called

for “The Department of Health [DOH] to design and establish by December 1, 2010, a

comprehensive electronic system to monitor the prescribing and dispensing of certain controlled

substances” (Office of General Counsel, 2009).

Two years after Senate Bill 462 had been passed, Florida had not initiated the

recommendations of a statewide database. According to the Palm Beach County Board of

County Commissioners (2011), the project to implement a prescription drug-monitoring program

(PDMP) had not been initiated due to delays, and Florida’s Governor, Rick Scott, had thought

about repealing the bill due to concerns of state funding and intrusion of patient privacy. Section

893.0551 (2)(b) addressed the funding concerns as it indicates that the funding will not come

from non-state monies, but through private and federal grants.

The department, when the direct support organization receives at least $20,000 in nonstate moneys or the state receives at least $20,000 in federal grants for the prescription drug monitoring program, shall adopt rules as necessary concerning





the reporting, accessing the database, evaluation, management, development, implementation, operation, security, and storage of information within the system, including rules for when patient advisory reports are provided to pharmacies and prescribers.

Additionally, section 893.0551 (2)(a) notes that the proposed electronic system should be

in compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA),

which provides privacy and security regulations along with rules regarding data breach

notification. By September of 2011, the electronic database was fully operational under the name

of E-FORCSE, Electronic- Florida Online Reporting of Controlled Substances Evaluation.

E-FORCSE

According to the Florida PDMP Foundation Inc. (n.d), in order for E-FORSCE to get the

private funding it needed to fully operate, the legislature had called for a non-profit tax-exempt

foundation to be established in order to seek that funding. Once the Florida PDMP Foundation

Inc. was established in 2011, there was no time wasted in putting it into effect. From 2011 E-

FORSCE has received funding from a variety of donors such as Sheriff’s office throughout

numerous Florida counties, private companies, and federal grants. The Managed Care Outlook

(2011) indicated that since the implementation of E-FORSCE in September 2011, 5,219

pharmacies have uploaded a total of 15 million controlled substance prescriptions. Additionally,

1,500 practitioners have already requested to view database information to view the patient’s

controlled prescription drug history. The Drug Policy Institute for the University of Florida’s

College of Medicine’s, Division of Addiction Medicine (n.d), E-FORSCE decreased the number

of doctor shopping by 35%, and it declined the number of oxycodone over dose related deaths by

17.7%.

Deonarine v. State


In 2001, one of Dr. Denis Deonarine’s patients passed away from a drug overdose. While

authorities investigated his death, they took an interest in the patient’s physician. After a senior

investigator from the Office of the Attorney General posed as a patient, enough evidence was

gathered to issue a warrant for his arrest. It was discovered that Dr. Deonarine had been

prescribing and dispensing controlled substances outside of the scope of professional medical

practice.

The defendant developed a friendly if not romantic relationship with one of his patients.

On the patient’ s initial consult with defendant she was given a prescription for 60 80mg

Oxycodone tablets without him reviewing her prior medical history or asking any questions

about her current medical condition. The only medical information he reviewed were some

imaging reports the patient had taken with her. The defendant continued to prescribe Oxycodone

to the patient on a regular basis, and in a course of three months the defendant had increased her

prescription. Furthermore, the defendant was aware that the patient had different pharmacies

where she would fill her prescriptions, which whom also was caught with an Oxycodone bottle

inside of her purse during the defendant’s search warrant at his office.

The defendant was prescribing controlled substances outside the scope of medical

practice with the disregard of safety for his patients. Defendant was charged and found guilty of

80 offenses, which include one count of first-degree murder, one count of racketeering, 53

counts of trafficking Schedule II drugs (oxycodone), and 25 counts of the sale/ delivery of

Schedule II drugs (diazepam & alprazolam). The defendant was clearly in violation of several

sections of Chapter 3, from the FL statute Article XLVI.

Why This Matters


The growing number of pill mills was a concern as Florida’s communities struggled to

fight against its prescription drug abuse problem. According to Ogle (2012), 98 out of 100

doctors who dispense oxycodone were concentrated in Miami and Orlando, and that in 2007 the

pill related deaths of Hillsborough County, FL had an increase of 65.2% from 2007-2010.

Moreover, Dutko (2010) emphasized on the dramatic increase of pain clinics in South Florida

which went from 60 to 150 in just one year and dispensing at least 6.5 million oxycodone pills

within a 6-month period. From 2003-2009 Florida saw an alarming rate of prescription overdose

deaths, and according to Correa (2011), there was an overall 84% increase during this 6-year

period with the highest rates being between Oxycodone, Alprazolam, and Methadone.

The new legislation that called for a prescription drug-monitoring program was

desperately needed to put in place restrictions and regulations on the accessibility of these

dangerous controlled substances. According to the 2014 Progress Report for the Statewide Task

Forces on Prescription Drug Abuse from the State Attorney’s Office, there were approximately

250 pain clinics shut down by 2013, and prescriber rates declined from 98 to 0 from 2010-2013.

Florida’s enforcement of tougher laws and regulations was the way to protect Florida

communities from prescription drug abuse, and those practitioners and pharmacies that engaged

in schemes that disregarded patient safety for heir own personal gains.

Subjective analysis

It seems as if the PDMP legislation in place has provided Florida the chance to clean up

its communities. According to the American Pharmacists Association (2015), has a total of 49

states that have adopted the PDMP. Moreover, APhA (2015) indicated that there has been a low

licensed prescriber registration rate of 35%. They also reported that only 22 states out of the 49


require prescribers to check the database, and 20 only states require physicians to register. In

order for states to successfully and effectively reap the benefits a PDMP offers they will have to

issue a mandate requiring all licensed controlled-drug prescribers to register through the PDMP

program through the state. Moreover, this mandate will also require all prescribers to look into

the database to view a patient’s controlled substance history before a new controlled substance

prescription is issued.

Conclusion

Florida’s illegal drug battle throughout the eighties is much similar to the prescription

drug abuse and overdose crisis it experienced due to the vast majority of pill mills available

throughout the state. Prior to 2009, Florida’s lax laws for controlled substances gave thousands

unregulated access to these dangerous drugs. The implementation of new legislation, such as the

SB 462, added a new section (Section 893.0551) to the Florida Statutes, which has called for a

statewide Prescription Drug Monitoring Program (PDMP) to track all prescriptions given for a

controlled substance. E-FORSCE has proven to be an effective tool in regulating the access of

these drugs. However, in order to fight the prescription drug battle effectively nationwide these

programs need to strictly be required by all states. Making states utilize their PDMP and making

it a requirement to register can assist win the battle.


References

American Pharmacists Association, Pharmacists Provider care. (n.d). Mandatory Use of

Prescription Drug Monitoring Programs. Retrieved from

http:://www.pharmacistsprovidecare.com/mandatory-use-of-prescription-drug-monitoring-

programs

Barrett, B., Moore, K., Pearson, J., Olge, A., Young, S. M. (2012). Clinical History and

Characteristics of Persons with Oxycodone-related deaths in Hillsborough County, Florida

in 2009. Forensic Science International, 223, 47-52 doi:10.1016/j.forsciint.2012.07.01

Campo- Flores, A. (2011, February 19). Fight over a fix for Florida 'pill mills'; Appalachian

region seeks tracking system to stem flow of painkillers, but costs, efficacy questioned.

The Wall Street Journal. Retrieved from

http://www.wsj.com/articles/SB10001424052748703961104576148753447131080

Controlled Substance Act, 21 U.S.C Chapter 13, Subchapter I, Part A: Introductory Provisions

Correa, F. (2011, October). Prescription drug overdoses up in Florida. Clinical Psychiatry News,

39(10), 7 doi: 10.1016/S0270-6644(11)70369-1

Deonarine V. State, 978 so. 2d 159 (FL, 2008)

Dutko, A. (2010). Florida’s Fight Against Prescription Drug Abuse: Prescription Drug

Monitoring Program. Nova Law Review,34, 739-765.

Florida Comprehensive Drug Abuse Prevention Act, Fl. Stat. Chapter 896 §§ 893.02-593.0551

Florida Health. (n.d). Funding for the E-FORSCE Database. Retrieved from

http://www.floridahealth.gov/%5C/statistics-and-data/e-forcse/funding/index.html

http://www.floridahealth.gov/%5C/statistics-and-data/e-forcse/funding/index.html

http://www.wsj.com/articles/SB10001424052748703961104576148753447131080


Florida PDMP foundation launches prescription drug monitoring program. (2011, November

15). Managed Care Outlook, 24(22), 4. Retrieved from

http://ezproxy.fiu.edu/http://go.galegroup.com/ps/i.do?id=GALE

%7CA273530489&v=2.1&u=miam11506&it=r&p=AONE&sw=w&asid=8e8e44989e51

0127e987065adaa6cce3

Florida PDMP Foundation, Inc. (n.d). Funding the E-FORSCE Database’s Operations. Retrieved

from http://www.flpdmpfoundation.com/donations/

Florida Office of Attorney General. (2014). Statewide Task Force on Prescription Drug Abuse &

Newborns, 2014 Progress Report. Retrieved from

http://www.myfloridalegal.com/webfiles.nsf/wf/jmee-9gus2x/$file/progressreportonline.p

df

Herter, B., Johnson, H., Mack, K., Paulozzi, L., Porucznik, C. (2014). Decline in Drug Overdose

Deaths After State Policy Changes- Florida, 2010-2012 (MMWR Report). Retrieved

from the Center for Disease Control website:

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6326a3.htm

Office of General Counsel. (2009). 2009 Legislative Summary Laws of Interest to Florida Law

Enforcement. Retrieved from http://www.fdle.state.fl.us/Content/getdoc/8389ffe6-3a87-

4267-83ee-049f71ee03f6/2009-Online-Summaries-062209.aspx

Palm Beach County Board of Commissioners, Legislative Affairs. (2011). Agenda Item Summary

(Agenda Item# 5A-2). Retrieved from http://www.pbcgov.com/pubInf/Agenda/20110315/5a2.pdf

University of Florida Division of Addiction Medicine, Drug Policy Institute. (n.d). Florida’s

PMDP: An Early Success Story of Tackling Florida’s Prescription Drugs Abuse

http://www.pbcgov.com/pubInf/Agenda/20110315/5a2.pdf

http://www.myfloridalegal.com/webfiles.nsf/wf/jmee-9gus2x/$file/progressreportonline.pdf

http://www.myfloridalegal.com/webfiles.nsf/wf/jmee-9gus2x/$file/progressreportonline.pdf


Epidemic. Retrieved from

http://www.dontdecriminalize.org/files/images/pages/PDMP_Primer_4-10.pdf

US Department of Justice, Drug Enforcement Administration. (n.d). DEA- Led Operation Pill

Nation Targets Rogue Pain Clinics in South Florida. Retrieved from

http://www.dea.gov/divisions/mia/2011/mia022411.shtml

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