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

1. Fighting Drug Diversion in Florida: Internet Pharmacies, PMPs and ePrescribing December 7, 2007

2. Office of Drug Control Established in law in 1999 by FS 397.332 Purpose: (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.

3. 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 abuse

4. 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 reported Most involved more than one drug Of those deaths, more than half were due to just EIGHT drugs

5. Illegal Drugs Are Killers

6. 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 necessity Filling prescriptions that are not valid Fraudulent use of DEA numbers to write illegal prescriptions Writing prescriptions for bogus patients and keeping the drugs or selling them Doctor shopping Stolen prescription pads

7. 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.

8. 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 liability. 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.

9. ODC and PMP Legislation (3 of 3) Estimated cost (FY 07 dollars) of a Florida PMP based on preceding program description:

10. 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

11. Success Stories Between 2005-2007, 326 individuals were arrested for diversion of pharmaceutical drugs. This resulted in $18.5M in assets seized. 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)

12. Internet Pharmacies Are Also A Leading Source Florida had also become Ground Zero for illegal internet pharmacy activity Consider the following DEA statistics Half of 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

15. 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 questionnaire. 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 prescriptions. 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.

16. 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.

17. 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 pharmacies. Florida Pharmacies now buying substantially less hydrocodone than national average Source: DEA

18. 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 substances 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 physicians. Specifies procedures for pharmacist to verify validity of prescription Limits prescriptions during an emergency (oral prescription) to 72 hour supply Required AHCA to create and maintain a website: www.fhin.net/eprescribe/ePrescribeIndex.shtml to educate Florida on ePrescribing

19. 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 done 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 counterfeited Signatures can be easily forged Drug quantities can be manually altered before the prescription is delivered to the pharmacy.

20. E-Prescribing can Help With Diversion Control The electronic audit trail allows for faster identification and investigation of possible abuse. 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 patient. Helps identify �doctor shopping� Addresses re-use of prescriptions.

21. 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 prescriptions. Therefore, �rogue� internet pharmacies would not be able to bypass these stringent safeguards.

22. e-Prescribing Infrastructure is Safe and Secure

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

24. E-Prescribing Pilot for Controlled Substances Controlled substances may not yet be e-prescribed 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

25. 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.

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

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