Kentucky All Schedule Prescription Electronic Reporting A KASPER

Kentucky All Schedule Prescription Electronic Reporting A KASPER Update for Family Physicians Jill E. Lee, RPh Investigator Drug Enforcement and Professional Practices Branch Office of Inspector General Kentucky Cabinet for Health and Family Services Kentucky Academy of Family Physicians March 28, 2015

Disclosure • Jill E. Lee – No relevant financial relationships. – No conflicts of interest. Cabinet for Health and Family Services

Contents • Controlled Substance Abuse • CS Use in KY • Legislative Changes Affecting Provider Use of KASPER • HB 1 Preliminary Results and Evaluation • How to Use KASPER effectively Cabinet for Health and Family Services

Objectives • Discuss statutory and regulatory prescriber responsibilities • Engage the Drug Enforcement and Professional Practices Branch for support • Recognize red flags that are indicative of doctor shoppers and • • Learn how to protect your practice Cabinet for Health and Family Services

Controlled Substance Abuse

Misuse, Abuse, Diversion • Misuse: – When a schedule II – V substance is taken by an individual for a non-medical reason. • Abuse: – When an individual repeatedly takes a schedule II – V substance for a non-medical reason. • Diversion: – When a schedule II – V substance is acquired and/or taken by an individual for whom the medication was not prescribed. Cabinet for Health and Family Services

Painkiller Prescription Rates by State CDC Vitalsigns July 2014, Source: IMS, National Prescription Audit (NPAtm), 2012 Cabinet for Health and Family Services

Painkiller Prescription Rates by State CDC Vitalsigns July 2014, Source: IMS, National Prescription Audit (NPAtm), 2012 Cabinet for Health and Family Services

Most Common Drug Treatment Admissions by State Laura Dimon, MIC Network, Inc. , February 10, 2014. Image credit: Fiona Breslin. Cabinet for Health and Family Services

Drug Overdose Death Rates in Kentucky Cabinet for Health and Family Services

Controlled Substance Usage 2014 Cabinet for Health and Family Services

It is epidemic! CDC declares epidemic of overdose deaths from opioid pain relievers in 2011 • Second leading cause of accidental death • Overdose increased 10 -fold since 1990 Who is to blame? • Pain charts – rate your pain? • Drug companies with their aggressive marketing techniques? Oxycontin 2000 s • The internet? Cabinet for Health and Family Services

Diversion and Overdoses Center for Disease control and Prevention, “Policy Impact: Prescription Painkiller Overdoses” http: //www. cdc. gov/homeandrecreationalsafety/rxbrief/ Cabinet for Health and Family Services

Heather Pereira Story reported by Ann Bowden, WLKY. com, December 8, 2014 Cabinet for Health and Family Services

Amanda Foster and Douglas Allen Cabinet for Health and Family Services

Danielle Cogswell Louisville Courier-Journal, August 29, 2014 Cabinet for Health and Family Services

Adderall & Ritalin Cabinet for Health and Family Services

Addiction Who is at Risk?

Primary Risk Factors for Addiction • Inheritance • Age of first use • Availability of addictive substances Cabinet for Health and Family Services

Who’s at Risk? • A first degree relative -4 x risk of Addiction • Use of an addictive substance before age 15 -5 x risk • Some develop Addiction without either • Approximately 15% of population Cabinet for Health and Family Services

Pill Mills

Jeff and Chris George Photos from Palm Beach Post Cabinet for Health and Family Services

Dr. Paul H. Volkman Story: Bill Estep, Lexington Herald-Leader, February 14, 2012. AP Photo released by U. S. Marshals Service (undated) Cabinet for Health and Family Services

Care More Pain Management Clinic Photo: Scott Utterback, Louisville Courier-Journal, January 25, 2012 Cabinet for Health and Family Services

Care More Pain Management Clinic Photo: Scott Utterback, Louisville Courier-Journal, January 25, 2012 Cabinet for Health and Family Services

Ernest William Singleton Photo: Lexington Community Corrections, January 2013 Cabinet for Health and Family Services

CDC Recommendations • Laws to prevent prescription drug abuse and diversion • Prescription Drug Monitoring Programs • Health care provider accountability • Better access to substance abuse treatment Cabinet for Health and Family Services

Combating Prescription Drug Abuse in Kentucky

Legislative Changes in Kentucky

KASPER Legislation • 2012 House Bill 1 “Pill Mill Bill” • 2013 House Bill 217 Cabinet for Health and Family Services

Pain Facility KRS 218 A. 175 - Pain Management Facilities • Physician ownership required • Subspecialty/certification required • Can not be a cash only business • Oversight Requirement Definition of a Pain Management Facility • A facility where majority of patients provided controlled substances for pain AND a. Primary practice component is treatment of pain b. Facility advertises any type of pain management services APRNs CANNOT OWN PAIN FACILITIES Cabinet for Health and Family Services

Non-Physician Owned PMFs • 29 non-physician owned PMFs were identified on April 24, 2012 (HB 1 passage date) • 8 closed prior to July 20, 2012 (HB 1 effective date) • 14 closed after the HB 1 effective date • 3 illegal or non-physician owned PMFs discovered after HB 1 effective date • 6 PMFs were sent cease and desist letters • 5 PMFs licensed by the Cabinet for Health and Family Services

Register for PMF Cabinet for Health and Family Services

You might be a pill mill if… • You feel compelled to hire “security” • Most people pay cash for their pills • Patients refer to their drugs by their street name or request specific color of pills • You have long lines that wrap around your building by 7 am. • Patients come from long distances to see you • You only write for the highest strength of pills • You often write for the “holy trinity” • You have been previously warned or disciplined by your medical board. Cabinet for Health and Family Services

The Kentucky Strategy • Limit prescriber dispensing to 48 hour supply (C-II or C-III containing hydrocodone) • Require 7. 5% of CME in addiction, pain management or KASPER • Develop educational materials and conduct training • Increase drug disposal opportunities • Increase treatment funding and resources Cabinet for Health and Family Services

218 A. 172 Required medical boards to create regulations, prior to the initial prescribing of a schedule II (or a C 3 with hydrocodone) • Medical history • Query KASPER • Make a written plan • Discuss risks and benefits • Obtain written consent Cabinet for Health and Family Services

. Prescription Monitoring Programs

Mandate KASPER Usage 2012 • Enhance use of Kentucky All Schedule Prescription Electronic Reporting System (KASPER) – Require daily reporting to KASPER – Mandate KASPER registration and usage – Utilize KASPER Advisory Council to identify inappropriate or illegal controlled substance prescribing Cabinet for Health and Family Services

e. KASPER Reporting KRS 218 A. 202 • Controlled substance administration or dispensing must be reported within one day effective July 1, 2013 • ASAP 4. 2 PDMP data collection standard required effective July 1, 2014 Cabinet for Health and Family Services

e. KASPER Prescriber Usage - KRS 218 A. 172 • Query e. KASPER for previous 12 months of data: – Prior to initial prescribing or dispensing of a Schedule II controlled substance, or a Schedule III controlled substance containing hydrocodone – No less than every three months – Review data before issuing a new prescription or refills for a Schedule II controlled substance or a Schedule III controlled substance containing hydrocodone • Additional rules/exceptions included in licensure board regulations Cabinet for Health and Family Services

KASPER Regulations – Licensure Boards • 201 KAR 5: 130 – Kentucky Board of Optometric Examiners KASPER requirements • 201 KAR 8: 540 – Kentucky Board of Dentistry KASPER requirements • 201 KAR 9: 260 – Kentucky Board of Medical Licensure KASPER requirements • 201 KAR 20: 057 – Kentucky Board of Nursing KASPER requirements • 201 KAR 25: 090 – Kentucky Board of Podiatry KASPER requirements. Cabinet for Health and Family Services

KBML web site Cabinet for Health and Family Services

Cabinet for Health and Family Services

Cabinet for Health and Family Services

Weight loss craze 201 KAR 9: 260 Restrictions on use of amphetamine-like anorectic C. S. Cabinet for Health and Family Services

Buprenorphine Cabinet for Health and Family Services

The KASPER Program

KASPER is Kentucky’s Prescription Monitoring Program (PMP). KASPER tracks Schedule II – V controlled substance prescriptions dispensed within the state as reported by pharmacies and other dispensers. Enhanced KASPER (e. KASPER) is the real-time web accessed database that provides a tool to help address the misuse, abuse and diversion of controlled pharmaceutical substances. Cabinet for Health and Family Services

Status of Prescription Drug Monitoring Programs (PDMPs) VT ME WA MT ND OR MN WI SD ID WY NE NV UT CO CA AZ KS OK NM AK MI IA IL IN PA OH WV VA NC TN SC AR LA DC KY MO MS TX NY AL NH MA RI CT NJ DE MD GA FL Operational PDMPs HI Enacted PDMP legislation, but program not yet operational Legislation pending GU Research is current as of February 1, 2012

2011 KASPER Reports Requested Cabinet for Health and Family Services

Annual KASPER Records Total / Person 2. 39 2. 43 2. 65 2. 72 2. 47 Number of Controlled Substance Prescriptions per Person Cabinet for Health and Family Services

KASPER Reports Requested Cabinet for Health and Family Services

Top Prescribed Controlled Substances by Therapeutic Category by Doses - 2014 Lorazepam 4. 0% Ativan Zolpidem 3. 6% Ambien Amphetamine 3. 3% Adderall Diazepam 4. 2% Valium Clonazepam 7. 0% Klonopin Tramadol 9. 0% Ultram Alprazolam 10. 8% Xanax Cabinet for Health and Family Services Oxycodone 15. 7% Oxy. Contin Percodan Percocet Phentermine 2. 9% Adipex-P Hydrocodone 39. 5% Lortab Lorcet Vicodin

KASPER Stakeholders • • • Licensing Boards – to investigate potential inappropriate prescribing by a licensee. Practitioners and Pharmacists – to review a current patient’s controlled substance prescription history for medical or pharmaceutical treatment. Law Enforcement Officers, OIG employees, Commonwealth’s attorneys, county attorneys - to review an individual’s controlled substance prescription history as part of a bona fide drug investigation or drug prosecution. Medicaid – to screen members for potential abuse of pharmacy benefits and to determine “lock-in”; to screen providers for adherence to prescribing guidelines for Medicaid patients. A judge or probation or parole officer – to help ensure adherence to drug diversion or probation program guidelines. Medical Examiners engaged in a death investigation Cabinet for Health and Family Services

Goals of KASPER • KASPER was designed as a tool to help address prescription drug abuse and diversion by providing: – A source of information for health care professionals – An investigative tool for law enforcement and regulatory agencies • KASPER was not designed to: – Prevent people from obtaining prescription drugs Cabinet for Health and Family Services

To Request an e. KASPER Report • Via secure WEB application. • Application accessible from any PC with WEB access. • Practitioners and pharmacists can receive a report often within 15 seconds (as long as the report does not require further review by the KASPER staff). • Available 24 / 7. • URL: https: //ekasper. chfs. ky. gov. Cabinet for Health and Family Services

e. KASPER Report Processing • 97% of reports auto-matched by e. KASPER • Manual Queue: – Processed 8: 00 a. m. to 4: 30 p. m. Monday through Friday – Weekday manual reports typically available within one hour Cabinet for Health and Family Services

Providing Reports to Patients – KRS 218 A. 202 • e. KASPER reports can be shared with the patient or person authorized to act on the patient’s behalf • e. KASPER reports can be placed in the patient’s medical record, with the report then being deemed a medical record subject to disclosure on the same terms and conditions as an ordinary medical record Cabinet for Health and Family Services

e. KASPER Report Request - Master Cabinet for Health and Family Services

e. KASPER Report Request - Master Cabinet for Health and Family Services

What if I cannot “Query” KASPER? • If e. KASPER indicates “manual process” – Record the e. KASPER report request number in the patient’s chart • If the e. KASPER system is unavailable or Internet access unavailable – Document circumstances why e. KASPER could not be queried – If e. KASPER outage, record the date and time Cabinet for Health and Family Services

When should I KASPER? • CS for pain or symptoms associated- Every 3 months • Other conditions beside pain- Before prescribing and then according to standards of acceptable and prevailing practice. • If you don’t know – every 3 months Note – APRN’s regs state no less than every 3 months. Cabinet for Health and Family Services

KASPER Query Exceptions (MD) • In an emergency situation • Within 14 days of surgery or within three days of oral surgery • Patients in hospitals and long term care facilities – Hospitals and long term care facilities can establish institutional accounts and request reports on behalf of the facility • Patients in Hospice care or being treated for cancer pain • Single doses of anxiety medicine prior to a procedure • Prescribing a substitute medication within 7 days of initial prescription Cabinet for Health and Family Services

e. KASPER Delegate Accounts – KRS 218 A. 202 • e. KASPER delegate accounts allowed for: – An employee of the practitioner’s or pharmacist’s practice acting under the specific direction of the practitioner or pharmacist Cabinet for Health and Family Services

e. KASPER Delegate Account Request Cabinet for Health and Family Services

Delegate Request Cabinet for Health and Family Services

e. KASPER Prescriber Reports – KRS 218 A. 202 • CS prescribers can obtain an e. KASPER report on themselves for any 90 day period: – To review and assess the individual prescribing patterns – To determine the accuracy and completeness of information contained in e. KASPER – To identify fraudulent prescriptions Cabinet for Health and Family Services

e. KASPER Prescriber Report Request Cabinet for Health and Family Services

Google KASPER – click link Cabinet for Health and Family Services

Reverse KASPER Cabinet for Health and Family Services

Why Reverse KASPER?

Signs of Diverters • • • High achievers Significant stresses in life Prefers night shift Takes on critical cases Works at more than one facility Smoker Disappears a lot Volunteers overtime Changes in personality Decline in job performance Cabinet for Health and Family Services

e. KASPER Error Correction - 902 KAR 55: 110 • Patient or provider should contact the dispenser to correct records in error • Inaccurate KASPER reports due to system errors should be reported to the Drug Enforcement and Professional Practices Branch – 502 -564 -7985 Cabinet for Health and Family Services

House Bill 1 Preliminary Results and Evaluation

Controlled Substance Dispensing – One Year Comparison Drug August 2011 through July 2012 August 2012 through July 2013 Hydrocodone 239, 037, 354 214, 349, 392 -10. 3% Oxycodone 87, 090, 503 77, 022, 586 -11. 6% Oxymorphone 1, 753, 231 1, 138, 817 - 35. 0% Alprazolam 71, 669, 411 62, 088, 568 -13. 4% Methylphenidate 10, 659, 840 11, 454, 025 + 7. 5% Amphetamine 13, 795, 147 15, 065, 833 + 9. 2% All Controlled Substances 739, 263, 679 676, 303, 581 -8. 5% Figures shown in doses dispensed Cabinet for Health and Family Services Change

Hydrocodone Cabinet for Health and Family Services

Oxycodone Cabinet for Health and Family Services

Alprazolam Cabinet for Health and Family Services

Diazepam Cabinet for Health and Family Services

Methadone Cabinet for Health and Family Services

Oxymorphone Cabinet for Health and Family Services

Tramadol Cabinet for Health and Family Services

Buprenorphine/Naloxone Cabinet for Health and Family Services

House Bill 1 Impact Study • Comprehensive assessment of HB 1’s impact on patients, prescribers, and other stakeholders • Overall goals: – Evaluate the impact of HB 1 on reducing prescription drug abuse and diversion in Kentucky – Identify unintended consequences associated with implementation of HB 1 that impact patients, providers and citizens of the Commonwealth – Develop recommendations to improve effectiveness of HB 1 and mitigate identified unintended consequences • Final study report planned for 4 Q 2014 Cabinet for Health and Family Services

Health care Accountability Protecting your Practice

Contents • • • Provider Shopping Advice from the Kentucky Licensure Boards KASPER Case Studies The Drug Enforcement and Professional Practices Branch Tips from DEPPB Controlled Substance Actions & Other Drugs of Concern Cabinet for Health and Family Services

Provider Shopping

Provider Shopping Provider shopping is when controlled substances are acquired by deception. Acts related to attempting to obtain a controlled substance, a prescription for a controlled substance or administration of a controlled substance, prohibited under KRS 218 A. 140 include: • • • Knowingly misrepresenting or withholding information from a practitioner. Providing a false name or address. Knowingly making a false statement. Falsely representing to be authorized to obtain controlled substances. Presenting a prescription that was obtained in violation of the above. Affixing a false or forged label to a controlled substance receptacle. Cabinet for Health and Family Services

Typical Provider Shopping Behaviors Patient Behaviors Examples Multiple providers of the same type 3 or more general practitioners, dentists, etc. Dispensers and prescribers are in different localities from each other and the patient’s home address Patient lives in Fayette county; prescriber in Franklin county; dispenser in Jessamine county Overlapping prescriptions of the same drug from different prescriber types Oxycodone scripts from dentist, family physician, and pain management doctor within 30 days Excessive emergency room visits for non-emergency issues 3 or more emergency room visits in a month for chronic pain conditions Requesting replacement for lost medications regularly Patient states that controlled substance is lost and requests new prescription Requesting early refills Patient requests early refills due to extended outof-state trip Pressuring prescribers to prescribe specific controlled substances for the patient’s family members Parent requests the pediatrician prescribe a specific controlled substance for their child stating that it is the only medication that works Cabinet for Health and Family Services

Typical Provider Shopping Behaviors (Cont. ) Patient Behaviors Examples Using multiple names, social security numbers, addresses, etc. Patient fills three scripts under three different names Seeking referrals to multiple pain management clinics Patient requests referrals to pain management clinics without a specific diagnosis Associating with others known to be pharmaceutical controlled substance provider shopping Patient travels to clinic with another patient exhibiting shopping behavior and requests similar prescription Self-mutilation Patient presents with potential self-inflicted wound Cash transactions Patient prefers to pay cash when insurance available Requesting partial dispensing of controlled substance script Patient requests half of the script and returns for the rest within 72 hours After-hour, weekend and holiday calls for prescriptions Patient calls prescriber at midnight on Friday to request a controlled substance script Cabinet for Health and Family Services

Doctor Shopping Targeted Provider Characteristics: • New providers • Senior providers • Providers perceived to keep substandard records • Pain management providers Cabinet for Health and Family Services

Substance Use Disorder Substance use disorder is an illness that sometimes drives a patient to perform activities that are illegal. It is important to remember that the patient who is provider shopping may have an underlying illness that can be diagnosed and treated. Cabinet for Health and Family Services

Practitioner Judgment Practitioners must use their best professional judgment to determine: • when to intervene with a provider shopping patient and provide treatment, or refer them to treatment • when to dismiss a patient or just not write controlled substance prescriptions for them • when to contact law enforcement to report a provider shopper Cabinet for Health and Family Services

KASPER Case Studies

KASPER Case Study 1 - Male Patient – Age 36

KASPER Case Study 2 (Page 1) - Male Patient – Age 45

KASPER Case Study 2 (Page 2) - Male Patient – Age 45

Advice from the Kentucky Licensure Boards

Fast tract to KBML/BON • Departures from or failures to conform to “acceptable and prevailing medical practices” (this includes prescribing violations and failure to sufficiently document clinical reasoning in general) • Boundaries issues (i. e. sex with patients or prescribing to intimates) • Failure to make timely reports ( i. e. failure to report criminal conviction/plea or any action against his/her license by another state licensing board within 10 days of event) • False statements on applications (answering “no” when should have answered “yes”) • Untreated substance abuse/dependence Cabinet for Health and Family Services

Protecting Your Practice Recommendations from the Kentucky Board of Medical Licensure and Kentucky Board of Nursing • Remain up to date with rules (guidelines) and regulations: – in the Medical Practice Act (available on KBML web site: www. kbml. ky. gov) – in the Nurse Practice Act (available on KBN web site: http: //kbn. ky. gov) • Keep well-documented patient records Cabinet for Health and Family Services

Protecting Your Practice (cont. ) • Be attentive to patient needs • Be familiar with office personnel and their interactions with patients • Remain up to date with current billing methods and insurance procedures • Maintain appropriate controls on prescription pads – Title 21 Code of Federal Regulations § 1306. 05(a) • No Pre-signed or post-dated prescriptions Cabinet for Health and Family Services

Protecting Your Practice (cont. ) • The Boards strongly encourage use of chaperones for sensitive examinations • Do not prescribe controlled substances for yourself or “immediate family”. • Run KASPER reports on patients. • Maintain appropriate controls/security on KASPER access. Cabinet for Health and Family Services

Protecting your practice (cont) • Writing controlled substance prescriptions for friends, co-workers, or employees • See 201 KAR 20: 057/ 201 KAR 20: 057 for all requirements • Chart with a KASPER in it, medical history, treatment plan, diagnostic examinations, documented consent, etc. . Cabinet for Health and Family Services

The Drug Enforcement and Professional Practices Branch (DEPPB)

Drug Enforcement Branch • The Drug Enforcement and Professional Practices Branch (DEPPB) is housed within the Cabinet for Health and Family Services: – Office of Inspector General (OIG) • Division of Audits and Investigations • DEPPB Responsibilities: – Enforcement of Kentucky Controlled Substances Act (KRS 218). • Conducting drug investigations. • Licensing drug manufacturers and distributors. – Enforcement of Kentucky Food, Drug and Cosmetic Act (KRS 217). – Operation of the KASPER program. Cabinet for Health and Family Services

DEPPB Investigators • Over the years DEPPB has migrated from a purely law enforcement agency to a consulting and assistance role in supporting investigations by other law enforcement agencies. • DEPPB investigators, by statute are all pharmacists thereby giving them a unique insight into drugs, provider and dispenser office procedures and record keeping/analysis. Cabinet for Health and Family Services

DEPPB Investigators DEPPB Phone Number: 502 -564 -7985 Paula York Jill Lee Amanda Ward Carrie Gentry Laura Beth Wells Duncan Mc. Cracken Cabinet for Health and Family Services Chris Johnson

Prescriber Review Considerations • Practitioner’s area of specialty • Consultation with licensure board to discuss any known problems with the practitioner • Review KASPER prescriber report • Total number of pages • Types of controlled substances prescribed (only a few types of controlled substances? ) • Prescribing unusually large quantities • Prescribing certain combinations (e. g. , hydrocodone, alprazolam and carisoprodol) • Refill frequency; are new scripts issued before all refills are exhausted? • Are patients traveling long distances to see the prescriber?

KASPER Case Study • Physician identified as one of top 10 prescribers of hydrocodone in Kentucky • The analysis was based on criteria established by the KASPER Advisory Council • Physician referred to Drug Enforcement and Professional Practices Branch for Review • DEPPB pharmacist/investigator reviewed KASPER report from 1/8/2011 to 1/8/2012 (498 pages) • Physician specialty identified by KBML as pain management • No prior complaints against physician • Physician wrote >50 controlled substance prescriptions on 23 days between 10/1/2011 and 12/31/2011 (67 working day period) • Physician used KASPER (running 783 KASPER reports on patients from 1/8/2011 to 1/8/2012) • DEPPB investigator indicated that the KASPER report did not provide any evidence of inappropriate prescribing, and no further action was taken.

Tips from DEPPB

Tips from DEPPB - 1 How to identify doctor shoppers and avoid becoming a victim! • Use KASPER. – New patients – Before prescribing a controlled substance – Periodically for patients receiving a controlled substance • Be suspicious if a patient requests specific or brand name drugs. • Require photo id for patient records. Cabinet for Health and Family Services

Tips from DEPPB - 2 • Be suspicious of vague or inconsistent patient complaints. • Be suspicious of patients coming with family members, all wanting the same medications or with the same complaint. • Is the patient carpooling to your office with other patients? • Do patients know each other? Are they possibly mingling in the parking lot after their visits? Cabinet for Health and Family Services

Tips from DEPPB - 3 • Check patient address. Are patients driving long distances to see the prescriber? • Be wary of patients asking for frequent early prescriptions due to vacations, or new prescriptions when they should still have refills available. • Be suspicious of patients claiming lost or stolen medications. Require a police report, or if you believe them limit them to one time. Cabinet for Health and Family Services

Tips from DEPPB - 4 • Require patient to sign drug or pain contract with the prescriber. – Consider limiting the patient to one pharmacy in the contract. • Perform random drug screens. • Secure your prescription pads – even from staff. Serialize your secure prescription pads. • Write prescriptions in longhand to prevent further tampering. Make copies for patient files for proof if altered. Cabinet for Health and Family Services

Tips from DEPPB - 5 • Be suspicious of patients stating they are allergic to NSAIDs. • If a patient presents an MRI, verify it is from a legitimate facility. • Be suspicious of patients who frequently show up late in the day or on Friday afternoon (hoping you will be too busy to ask many questions or conduct a thorough examination). Cabinet for Health and Family Services

Tips from DEPPB- Prescribing • Identify yourself on prescription If there are 6 doctors and 4 APRN’s at your office listed on the prescription blank, make sure you circle your name. • Clearly identify the patient Be sure to write the patient’s full name on the prescription, including any suffixes. Include the patient address and date of to reduce fraudulent activity. • Spell out quantities and refills in addition to writing or circling the number on the prescription • Make copy of prescription for chart • Cancel Refills Cabinet for Health and Family Services at the pharmacy if changing medication birth

Security Prescription Blank (902 KAR 55: 105) A latent repetitive VOID at 5% in Pantone Greenif copied Void appears in pattern across entire script Federal Law Requires Prescriber Name, Address and Registration (DEA#) ¾ inch Opaque Rx Symbol 1/8 in. from top, 5/16 in. from side Rx is 4 ¼ inch high and 5 ½ inch wide 6 Quantity Check-Off Boxes The following statement at bottom of blank Refill Options on Left Side in this order Prescription is void if more than one (1) prescription is written per blank Printed Watermark on Back: “Kentucky Security Prescription” Horizontal– 5 lines-Helvetica style

Tips from DEPPB- Rx Blanks • Order controlled substance blanks that meet state security requirements – KAR 55: 105 • Store Rx pads in a secure spot – even from office staff • Do not pre-sign Rx blanks • Do not use Rx blanks pre-signed by your collaborative physician • Do not post-date prescriptions: All written and facsimile prescriptions for controlled substances shall be dated and signed by the practitioner on the date issued and shall bear the full name and address of the patient, drug name, strength, dosage form, quantity prescribed, directions for use, and the name, address and registration number of the practitioner • Scripts for compounded controlled substances are not exempt from controlled substance laws Cabinet for Health and Family Services

Questions to ask the Patient! • Are you seeing other practitioners for this or any other reason? • When did you last see the other practitioner? • What medications were you prescribed? • What pharmacy did you use? • Request identification with photo, DOB, SSN and address. Compare the above information with the KASPER report. Cabinet for Health and Family Services

APRN Tips from DEPPB-Know the limits Jlee 2014 Cabinet for Health and Family Services

Sources of Confusion § Unless you are certified as a psych/mental heath APRN, you cannot write for more than a 72 hour supply of a C-II psychostimulant (ADHD meds). § Even if you are certified as a psych/mental health APRN, you cannot write for more than a 72 hour supply of any other C-II. § APRNs cannot write Suboxone prescriptions for addiction; only physicians can be Data Waived § APRNs cannot issue multiple prescriptions (see KRS 314. 011) § Nubain (not federally scheduled) –schedule IV in Ky § Talwin (pentazocine), Phenobarb, and all butalbital are schedule III in KY Cabinet for Health and Family Services

Sources of Confusion (Cont. ) • APRN’s cannot dispense controlled substance medications- see KRS 314. 011 (8) • APRN’s cannot order controlled substances to dispense in office • APRN’s can not supervise a PA-C – only physicians can supervise- see KRS 311. 840 • Weight Loss Clinics/Amphetamine like substances Can not dispense meds if doctor not in office Must conform to standards of practice Cabinet for Health and Family Services

Dispensing CS from office • All administered and dispensed controlled substances must be reported to KASPER (doctor’s offices are not exempt and must adhere to all the reporting laws as pharmacies do) • Only pharmacist and physicians are allowed to dispense medication (not APRNs, PAs, RNs, office staff) Cabinet for Health and Family Services

Multiple prescriptions • A practitioner may provide individual patients with multiple prescriptions for the same schedule II controlled substance to be filled sequentially. The combined effect of these multiple prescriptions is to allow the patient to receive, over time, up to a 90 -day supply of that controlled substance APRNs may not issue multiple prescriptions Must adhere to prescribing standards in 201 KAR 9: 290 Cabinet for Health and Family Services

Diversion Definition- When a substance is acquired and/or taken by an individual for whom the medication was not prescribed. What do you do when diversion is suspected? • If you suspect an individual is involved in diverting controlled substances, we ask that you please report them to the proper law enforcement authorities. • If unsure who to contact please call the Drug Enforcement and Professional Practices Branch of the Office of the Inspector General for assistance. – (502) 564 -7985 – http: //www. chfs. ky. gov/os/oig/auditsinv Cabinet for Health and Family Services

Diversion Reporting Provider Shoppers/Diverters • KRS 218 A. 280 Controlled substances – Communications with practitioner not privileged. – Information communicated to a practitioner in an effort unlawfully to procure a controlled substance, or unlawfully to procure the administration of any controlled substance, shall not be deemed a privileged communication. Cabinet for Health and Family Services

Reporting Provider Shoppers/Diverters • 902 KAR 55: 110 Section 10 (4) (b): In addition to the purposes authorized under KRS 218 A. 202(8)(e), and pursuant to KRS 218 A. 205(2)(a) and (6), a practitioner or pharmacist who obtains KASPER data or a report under KRS 218 A. 202(6)(e)1. or who in good faith believes that any person, including a patient, has violated the law in attempting to obtain a prescription for a controlled substance, may report suspected improper or illegal use of a controlled substance to law enforcement or the appropriate licensing board. Cabinet for Health and Family Services

Controlled Substance Actions and Other Drugs of Concern

Federal Actions • FDA approved C-II pure hydrocodone product – Zohydrotm ER manufactured by Zogenix, Inc. – Available March 2014 – Not abuse-resistant formulation • Tramadol scheduled federally C-IV – • Effective August 20, 2014 Hydrocodone combination products rescheduled to C-II – Effective October 6, 2014 Justice & Public Safety Cabinet

Kentucky Actions - Butalbital • The KY controlled substance exempt list now mirrors the Federal exempt list found in Title 21 Code of Federal Regulations § 1308. 32 EXCEPT butalbital containing products (e. g. , Fioricet, Bupap, Esgic). • Effective September 17, 2014 all butalbital containing products are Schedule III controlled substances in KY and must be reported to KASPER. Cabinet for Health and Family Services

Prescription drugs • • Clonidine Cyclobenzaprine Gabapentin Promethazine – Purple drank=promethazine/codeine cough syrup • Seroquel – Q-ball Cabinet for Health and Family Services

Clonidine • Reduce sx of alcohol and opioid withdrawal • Causes euphoria, hallucinations, & sedation • Use at high doses (2 mg+) causes hypomanic excitation • Boost effects of benzos, cocaine, opioids • Withdrawal= rebound HTN Cabinet for Health and Family Services

Gabapentin • Cocaine-like high when snorted • Used with other substances to potentiate effects • Can reduce craving for alcohol Cabinet for Health and Family Services

Promethazine • Promethazine w/ codeine Very popular with teens – Purple Drank typically mixed with sprite or Mt Dew and optionally a Jolly Rancher added for sweetness. • Plain promethazine potentiates the effects of just about every drug Cabinet for Health and Family Services

Atypical Antipsychotics • Used to potentiate high from other drugs or avoid AE • St. Luke’s and Roosevelt Hospitals in NYC: – 73 of 429 patients in detox/rehab units used atypical antipsychotics illegally/non-medically – 88% of atypical antipsychotic users were polysubstance users – 84. 9% used quetiapine Presented at American Academy of Addiction Psychiatry 24 th Annual Meeting & Symposium. 2013. Cabinet for Health and Family Services

Stimulants • Immediate release formulations preferred – Rapid increase in dopamine = Euphoria • Used for energy (“study drugs” for college age students) and weight loss • Cardiovascular dangers at high doses: BP spike, hyperthermia, stroke, arrhythmia Red Flags- claims of lost prescriptions, reports of Missing meds, early RF and higher dose request Cabinet for Health and Family Services

Street Value • http: //streetrx. com • Louisville, KY – Adderall 30 mg = $4 -5 – Lorazepam 0. 5 mg= $5 – Vyvanse 60 mg= $10 • http: //www. bluelight. org open information board about how to take legal/non-legal drugs Cabinet for Health and Family Services

Philip Seymour Hoffman US Weekly Celebrity News, February 3, 2014 Cabinet for Health and Family Services

Heroin vs. Oxy. Contin Source: National Survey on Drug Use and Health Oxy. Contin users (for nonmedical reasons) Heroin users Cabinet for Health and Family Services

Heroin Source: Kentucky Justice & Public Safety Cabinet for Health and Family Services

Heroin Cabinet for Health and Family Services

How Did We Get Here? • • • Long history of opioid/painkiller abuse Increasing numbers of IV drug usage Abuse deterrent formulations Crackdown on rogue pain clinics Greater awareness by prescribers Established drug cartels recognized increasing demand Cabinet for Health and Family Services

How Did We Get Here? PRICE AVAILABILITY PERCEPTION OF RISK Cabinet for Health and Family Services

How Do We Address the Problem? • Public Education • Increased access to treatment • Enhanced penalties for major traffickers • Greater access to naloxone Cabinet for Health and Family Services

KY Kids Recovery Program • $19. 2 million in funding for adolescent substance abuse treatment • Expanding treatment beds at existing facilities • Developing new treatment facilities • Providing full continuum of care including intensive outpatient and follow up • 19 substance abuse treatment grants awarded by Governor Beshear’s Substance Abuse Treatment Advisory Committee • www. kykidsrecovery. ky. gov Cabinet for Health and Family Services

The Take-Away Messages • • • Recognize the problem Report to police diversion The Drug Enforcement and Professional Practices Branch is available to support your practice. Use KASPER regularly Increase your knowledge of addiction & how to properly prescribe CS. Please remain alert and be careful! Cabinet for Health and Family Services

House Bill 1 Impact Study • Comprehensive assessment of HB 1’s impact on patients, prescribers, and other stakeholders • Overall goals: – Evaluate the impact of HB 1 on reducing prescription drug abuse and diversion in Kentucky – Identify unintended consequences associated with implementation of HB 1 that impact patients, providers and citizens of the Commonwealth – Develop recommendations to improve effectiveness of HB 1 and mitigate identified unintended consequences • Final study report planned for 1 Q 2014 Cabinet for Health and Family Services

KASPER Web Site: www. chfs. ky. gov/KASPER 502 -564 -7985