Medical Release Form for Individuals in Florida - PowerPoint by jwj34226


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									Andrew Benard
Florida Office of Drug Control
Executive Office of the Governor

   December 7, 2007

  Fighting Drug Diversion in Florida: Internet
  Pharmacies, PMPs and ePrescribing
Office of Drug Control

Established in law in 1999 by FS 397.332

  (a) Coordinate Florida’s drug control policies

       –   Develop a new state strategy for 2011

  (b) Act as the Governor's liaison

  (c) Secure funding

   (d) Advise the Governor and the Legislature

   (e) Provide information to the public.

Office of Drug Control

Mission Statement: The Governor’s Drug Control
 Office and the Statewide Drug Policy Advisory
 Council establish and institutionalize statewide
 drug control policy-making based on a process of
 long-range planning, information gathering,
 strategic decision-making, continuous oversight,
 and inter-agency coordinated funding.
     This is the most far-reaching initiative in the history of
      Florida’s efforts to combat the devastation of substance

Diversion Control: A Major Priority

 Drug diversion by clinicians, pharmacies and
  patients is a major problem in Florida
 Illegal drugs are killing our families, friends
  and neighbors
       In 2006, 7,741 drug-related deaths were
          Most   involved more than one drug
       Of those deaths, more than half were due to
        just EIGHT drugs

Illegal Drugs Are Killers

         Main Causes of Drug-Related Deaths
                  in Florida, 2006

                  Hydrocodone 6%      Morphine 6%
                                                                    Cocaine 21%
           Ethyl Alcohol 10%

         Alprazolam 12%
                                                                             Methadone 18%

                    Oxycodone 13%
                                                    All Benzodiazepines

       Source: 2006 MEC Drug report

Physicians and Non-Internet Pharmacies Contribute
to the Problem

ODC began efforts in 2001 to enact a Prescription
  Monitoring Program (―PMP‖) to counteract:
 Prescriptions for which there is no medical
 Filling prescriptions that are not valid
 Fraudulent use of DEA numbers to write illegal
 Writing prescriptions for bogus patients and
  keeping the drugs or selling them
 Doctor shopping
 Stolen prescription pads

ODC and PMP Legislation (1 of 3)

   FL DOH shall contract for the design, establishment, and
    maintenance of an electronic system consistent with
    standards of the American Society for Automation in
    Pharmacy to monitor the prescribing and dispensing of
    controlled substances listed in Schedules II, III, and IV
   Any controlled substance listed in Schedule II, Schedule
    III, or Schedule IV that is dispensed to an individual in this
    state must be reported to the department's contract
    vendor through the PMP as soon as possible, but not more
    than 35 days after the date the controlled substance is
    dispensed (Reactive).
   A prescription for a controlled substance listed in Schedule
    II may be dispensed only upon a written prescription of a
    practitioner, except that in an emergency situation, such
    controlled substance may be dispensed upon oral
    prescription but is limited to a 72-hour supply.
ODC and PMP Legislation (2 of 3)

   Any contractor entering into a contract under this section is
    liable in tort for the improper release of any confidential
    information received in addition to any breach of contract
   A practitioner or pharmacist authorized to obtain
    information under this section is not liable for accessing or
    failing to access such information.
   DOH shall develop and adopt by rule the form and content
    for a counterfeit-resistant prescription blank that may be
    used by practitioners to prescribe a controlled substance
    listed in Schedule II, Schedule III, or Schedule IV.
   Required reports of law enforcement agencies and medical
    examiners to include specified information if a person dies
    of an apparent overdose of a controlled substance listed in
    Schedule II, Schedule III, or Schedule IV.

ODC and PMP Legislation (3 of 3)

   Estimated cost (FY 07 dollars)
    of a Florida PMP based on
    preceding program description:

                                 1st Year   Recurring
      Position(s) FTE,
      Contract, County,              3          3
      General      Revenue     $2,564,670   $2,564,670
      Nonrecurring General     $1,837,677      $0
      Total                    $4,402,347   $2,564,670

ODC spearheaded the creation of Diversion
Response Teams in absence of comprehensive PMP

   Diversion Response Teams: Integrated
  task force consisting of co-located state and
  federal agencies
 Mission: To reduce the illicit diversion of
  prescription drugs statewide.
 Inter-agency intelligence sharing
 Emphasis on bad doctors, corrupt pharmacies and
  individuals assisting in diversion
 Culminate with license suspensions, revocations,
  arrests and indictments

Success Stories

   Between 2005-2007, 326 individuals were
    arrested for diversion of pharmaceutical
    drugs. This resulted in $18.5M in assets
   In terms of prescription diversion, doctors
    and pharmacists have been disciplined for
    possible drug diversion violations
      2006 – 60 Doctors & 75 Pharmacists
      2007 - 23 Doctors & 10 Pharmacists (as
       of 5/3/07)

Internet Pharmacies Are Also A Leading Source

   Florida had also become Ground Zero for
    illegal internet pharmacy activity
       Consider the following DEA statistics
          Halfof the top 10 highest hydrocodone purchasing
           pharmacies were located in Florida in 2006
          While the national monthly average was about 7,500
           dosage units, these Florida pharmacies average 3.6
           MILLION dosage units

 Florida Pharmacies in Top 10: 5   Florida Pharmacies in Top 25: 10

Monthly Average U.S.: 7,500 tabs.
Monthly Average Florida’s High 5: 3.6 million tabs.

                                   National Average: 90,967 tabs.
                                   Florida Average: 95,909 tabs.
                       90,967 tabs

Florida Pharmacies:
# 1: 15,596,380 tabs
# 2: 9,677,976 tabs
# 3: 9,082,010 tabs
# 4: 4,733,290 tabs
# 5: 4,564,480 tabs
# 6: 4,220,840 tabs
# 7: 3,882,320 tabs
# 8: 3,404,990 tabs
# 9: 3,258,160 tabs
#10: 2,731,420 tabs
                                     61,151,226 total d.u.
A Significant Case Example

   Beginning in 2004, a web-based company advertised and sold
    controlled substances and on-controlled prescription drugs. Customers
    were not required to have a valid prescription or any contact with a
    prescribing doctor. Instead, they had to complete a minimal
   The website owner/operators had agreements with doctors in FL, GA
    and WI to use a doctor’s DEA number to authenticate prescriptions, as
    well as with several pharmacies in FL and elsewhere to fill the
   Seven search warrants were executed at various locations around the
    country, including 5 in FL. This investigation revealed that a FL
    pharmacy purchased almost 2 million doses of hydrocone products,
    and another almost 1.3 million, compared to 2,000 doses for the
    average pharmacy.

Success Stories: Internet Pharmacies

   DEA and State authorities closed 16 internet
    pharmacies in the Tampa area in 2006
       Online pharmacies are having a more difficult time
        obtaining drugs due to federal and state efforts

   Example:
       One investigation revealed that pharmaceutical drugs
        were ordered from a business that utilized a stolen
        identity and DEA number of a licensed doctor and has
        resulted in the seizure of over 500,000 pharmaceutical
        pills, over $220,000 in currency and two arrests.
        Additional arrests are anticipated.

Now It’s A Different Story

   Thanks to aggressive efforts by Federal and state
    law enforcement and the DEA in Florida
       Criminal investigations, along with administrative
        initiatives, are having a major impact on internet
        diversion from Florida pharmacies
       Now only two Florida pharmacies on list of Top 25
        purchasers of hydrocodone; none in Top 10
       Equally compelling is the dramatic decrease in the
        quantities of hydrocodone purchased by Florida
          Florida Pharmacies now buying substantially less hydrocodone
         than national average

    Source: DEA

HB 1155/SB 893 REP. Gayle Harrell and SEN Burt
Saunders sponsored legislation - PASSED (2007)

     Prohibits sale, manufacture, alteration, delivery, uttering or
      possession of counterfeit-resistant blanks for controlled substances.
     Creates penalty-3rd degree felony
     Provides additional requirements for dispensing controlled
          Schedule II (morphine, oxycontin, methadone, etc)
          Schedule III (anabolic steroid, codeine etc)
          Schedule IV (valium, librium, Phenobarbital etc)
     Requires DOH to develop rule for form and content of
      counterfeit-proof prescription blank for voluntary use by
     Specifies procedures for pharmacist to verify validity of
     Limits prescriptions during an emergency (oral prescription) to
      72 hour supply
     Required AHCA to create and maintain a website: to educate
      Florida on ePrescribing
More needs to be done: e-Prescribing Can Help

   Despite the focused efforts of law enforcement
    and the many success stories, more needs to be
   E-prescribing offers new tools for law enforcement
   E-prescribing is far safer and more secure than
    paper prescriptions.
       Paper prescription pads are often stolen or
       Signatures can be easily forged
       Drug quantities can be manually altered before the
        prescription is delivered to the pharmacy.

E-Prescribing can Help With Diversion Control

   The electronic audit trail allows for faster
    identification and investigation of possible
   Computerization and data sharing can help
    identify improper prescriptions and patterns
    of irregular use.
        Since e-prescribing passes directly from the
        doctor to the pharmacy, there is no
        opportunity for abuse or diversion by the
        Helps identify ―doctor shopping‖
    Addresses re-use of prescriptions.

E-Prescribing Can Help With Diversion Control

   Data can be easily shared with e-prescribing.
       No need for paper-based databases that require manual
        entry and number crunching, and do not ―talk‖ to other
        data bases
   The e-prescribing infrastructure is a closed
    system. In order to receive e-prescriptions,
    pharmacies must be registered and certified to
    access the secure networks transmitting the
       Therefore, ―rogue‖ internet pharmacies would not be
        able to bypass these stringent safeguards.

e-Prescribing Infrastructure is Safe and Secure

   The e-prescribing infrastructure is in place at
  the front end for securely checking and
  transmitting formulary, benefit and medication
  history to the point of care
   The e-prescribing infrastructure is in place at
  the back end to securely transmit the
  prescription to the pharmacy
   The e-prescribing infrastructure is standards
  based, and meets or exceeds industry and HIPAA
  standards for privacy and security
      Also   meets or exceeds applicable state requirements

E-Prescribing and Non-repudiation

 E-prescribing system records can offer
  equally valid legal evidence of ownership
 The e-prescribing infrastructure can provide
  a mechanism for third-party auditing
  (Doctors, Pharmacists and Law
  Enforcement) and establish accountability
  for the prescriber.

E-Prescribing Pilot for Controlled Substances

 Controlled substances may not yet be e-
 Pilot projects are needed
 Florida is a perfect environment for a pilot
     Drug diversion is a major issue in Florida
     Floridians deserve to realize the safety, quality
      and cost-saving benefits of e-prescribing for all
      their medications

Pilot Requirements

    A vendor or vendors willing to make the necessary
     system modifications to accommodate e-
     prescribing of controlled substances
    A pharmacy chain or chains vendor willing to make
     the necessary system modifications to
     accommodate claims and provide medication
     history for e-prescribing of controlled substances.
    A payer or payers willing to make the necessary
     system modifications to accommodate claims and
     provide medication history for e-prescribing of
     controlled substances.

Pilot Requirements

 Physicians willing to participate—especially those
  in specialties that write a high volume of
  controlled substances, such as oncology and pain
 Sufficient volume of prescriptions for controlled
Geographic site, such as a county
 Permission from state and federal officials
       May require waivers to deviate from current system


   Florida     Needs a PMP
   Florida needs to embrace new, effective
    technology wherever possible to reduce deaths
   E-prescribing can help
       Issafer and more secure than paper prescriptions
       Offers real-time tools and useful features for both
        physicians and law enforcement


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