1 Solutions & Strategies for Preventing and Reducing Opioid OverdoseCameron McNamee Director of Policy and Communications

2 Policies Mandatory PDMP use. Expanding access to naloxone.

3 Mandatory PDMP Use Recommendation 2.1 Mandate prescriber PDMP use.

4 Mandatory PDMP Use For Prescribers:HB 341 (130th General Assembly) – Enacted April 2015. For Pharmacists: Rule – Drug Utilization Review – Enacted February 2016.

5 Drug Overdose Statistics3,050 Ohioans died of an unintentional drug overdose in 2015. 21.9% involved prescription opioids (narcotic painkillers). 16.5% involved benzodiazepines (anti-anxiety). Of those, 2,265 (74.2%) of those had a record of receiving a prescription controlled substance.

6 Ohio Automated Rx Reporting System (OARRS)Ohio’s Prescription Drug Monitoring Program (PDMP) A system which collects prescription information from pharmacies, stores it in a secure database, and produces patient-specific reports for healthcare professionals and law enforcement officers. 49 states, the District of Columbia, and the territory of Guam have a PMP. Missouri is the only state without a PMP.

7 What is OARRS? Web-based system authorized by ORC 4729.75.In operation since October 2, 2006. Collects approximately 25 million Schedule II-V controlled substance transactions each year. All pharmacies licensed by OSBP and prescribers who personally furnish controlled substances (except veterinarians) must submit data within 24 hours. VA facilities report outpatient prescriptions to OARRS within 24 hours.

8 Why OARRS? OARRS is designed to monitor this information for suspected abuse or diversion (i.e., the transfer of legally prescribed drugs for illegal use). Provides a prescriber or pharmacist critical information regarding a patient’s controlled substance prescription history. This information can help prescribers and pharmacists identify high-risk patients who would benefit from early interventions.

9 Why OARRS? Top 10 “Doctor Shoppers” 2006

10 2013 Legislative Study CommitteePrescription Drug Addiction and Healthcare Reform Study Committee. Heightened interest in OARRS. During study committee, Board provided testimony and demonstration of OARRS.

11 2013 Legislative Study CommitteeTestimony highlighted the underutilization of the system: No. of OARRS Rx Written 2013 1-15 16-100 501+ % of Ohio Prescribers 25% 26% 24% How much of Ohio’s Rx? 3% 4% 12% 81% How many have OARRS accounts? 33% 52% 74%

12 2013 Legislative Study Committee16% of prescribers (including their delegates) with accounts who wrote for more than 500 controlled substance prescriptions have never logged into OARRS. Additionally, 57% of prescribers (including their delegates) who wrote for more than 500 controlled substance prescriptions have not accessed the system in the past year.

13 Ohio HB 341 Initial legislation required use of OARRS prior to prescribing any schedule II controlled substances. Faced opposition from most prescriber groups.

14 Addressing OppositionPerfect be the enemy of the good. Ideal for checks prior to all CS prescribing. Data driven approach. Reviewed data from the Ohio Department of Health to determine drug classes responsible for unintentional drug overdoses. Included exemptions to win support of prescriber groups.

15 Required Use Of OARRS House Bill 341 - Effective April 1, 2015Required to review OARRS data when initially prescribing or personally furnishing an opioid or benzodiazepine to an Ohio patient. Exceptions Less than 7 day supply Hospice, cancer, or end-of-life care Immediately following surgery or other invasive procedure (only applies to physicians) Registration required upon license renewal for practicing pharmacists and prescribers who prescribe opioids/benzos.

16 Required Use Of OARRS The prescriber must also make periodic requests for patient information from OARRS if the course of treatment continues for more than 90 days. The requests must be made at intervals not exceeding ninety days, determined according to the date the initial request was made. Law change allows OARRS report to be included in patient’s medical record.

17 OARRS Rules For PharmacistsExcept for mandatory registration, HB 341 was silent on pharmacist requirements. Initial regulations promulgated in 2011 required use for signs of abuse. Board recognized role of pharmacist in addressing opioid abuse.

18 OARRS Rules For PharmacistsOAC – Prospective Drug Utilization Review (DUR) Corresponding responsibility : “a pharmacist shall use professional judgment when making a determination about the legitimacy of a prescription. A pharmacist is not required to dispense a prescription of doubtful, questionable, or suspicious origin.”

19 OARRS Rules Change OAC , Prospective DUR (effective 2/1/16) Prior to dispensing an outpatient prescription for a reported drug, a RPh shall request & review an OARRS report, including a border state’s PMP when the pharmacist is practicing pharmacy in a county bordering another state, for a one year period of time, if:

20 OARRS Rules Change 1. A patient adds a different or new reported drug to their therapy that was not previously included 2. OARRS report has not been run > 12 months as indicated on the patient profile 3. A prescriber is outside the pharmacy’s usual geographic area

21 OARRS Rules Change 4. A patient is outside the pharmacy’s usual geographic area 5. RPh suspects patient has received prescriptions for reported drugs from more than one prescriber in the preceding 3 months, unless prescriptions are from prescribers who practice at same physical location 6. Patient is exhibiting signs of potential abuse or diversion

22 Implementation For Prescribers:Comprehensive prescriber FAQ document developed and disseminated through professional licensing Boards. Updates to OARRS website to include new educational resources including video tutorials. (www.ohiopmp.gov) Enhanced features (including online registration and password resets). Quick reference guide.

23 Implementation For Pharmacists: Free online continuing education.Educational materials (quick reference guide). Its OK to Say No campaign.

24 Pharmacist and Prescriber Pocket Card

25 Its OK to Say No… www.pharmacy.ohio.gov/OKtoSayNo

26 Promising Statistics

27 *Patients may include exempted patients (i.e. hospice or cancer).OARRS Use Compliance August 2016 – According to Data from OARRS: Top 25 Physicians* did not run an OARRS report on a total of 7,499 patients. Top 25 APRNs* did not run an OARRS report on a total of 2,678 patients. Top 25 Dentists did not run an OARRS report on a total of 144 patients. *Patients may include exempted patients (i.e. hospice or cancer).

28 OARRS Use Compliance Letters sent to most prescribers not in compliance. OARRS queries increased from 83,544 to over 96,300 per weekday. Compliance reports automatically generated on a monthly basis. Pharmacy Board working on similar compliance efforts for pharmacists. Compliance self-monitoring report in development.

29 Evaluation Working with Ohio Department of Health to evaluate impact of prescriber mandates. Will include analysis of exemptions currently listed in the law. Plans to conduct additional analysis of pharmacist mandates in 2017.

30 OARRS Integration 10/26/15, Governor announced a $1.5 million/year to integrate OARRS directly into electronic medical records and pharmacy dispensing systems across the state, allowing instant access for prescribers and pharmacists. For more information –

31 Kroger Case Study Prescriptions Filled by Kroger in 2014: 3,121,520 Requests made by Kroger pharmacists in 2014: 310, Request to Prescription Ratio: 9.95% Prescriptions Filled by Kroger in August, 2015: 253,694 Requests made by Kroger in August, 2015: 254,347 August 2015 Request to Prescription Ratio: %

32 Expanding Access to Naloxone

33 About Naloxone Naloxone (Narcan®) is a safe medication that can reverse an overdose that is caused by prescription opioids, heroin and fentanyl. When administered during an overdose, naloxone blocks the effects of opioids on the brain and can restore breathing in a matter of minutes.

34 About Naloxone

35 Naloxone – HB 4 HB 4 (Rezabek & Sprague) signed into law on July 16, 2015. Authorizes a pharmacist or pharmacy intern under the direct supervision of a pharmacist to dispense naloxone without a prescription in accordance with a physician-approved protocol. Permits a physician to authorize one or more individuals to personally furnish a supply of naloxone pursuant to a protocol.

36 Naloxone – HB 4 Naloxone can be personally furnished or dispensed to the following: An individual who there is reason to believe is experiencing or at risk of experiencing an opioid-related overdose; or A family member, friend, or other person in a position to assist an individual who there is reason to believe is at risk of experiencing an opioid-related overdose.

37 Pharmacy Dispensing Any formulation of naloxone that is approved in the protocol can be dispensed (intramuscular, auto injector or intranasal). Any pharmacy dispensing pursuant to a protocol must notify the Board of Pharmacy within 30 days. Process automated and completely paperless. The law does not limit the number of protocols a physician may authorize therefore a physician may authorize a protocol for a number of pharmacy locations.

38 Naloxone in the PharmacyDeveloped dedicated resources for pharmacies. Website includes: Sample protocol. Frequently asked questions. Brochure (English and Spanish) Printed brochures offered to pharmacies at no-cost.

39 Naloxone in the Pharmacy

40 Naloxone at Pharmacies www.pharmacy.ohio.gov/stopoverdose

41 Naloxone in the Pharmacy1,375 Ohio retail pharmacies (65%) offer naloxone without an Rx. 84 out of 88 counties offer naloxone without a prescription. Conducting targeted outreach to remaining chains and independents. Focusing on counties with less than 50% of pharmacies offering naloxone without an Rx.

42 Additional ConsiderationsPermitted non-pharmacists (i.e. technicians or other delegates) to conduct training at the pharmacy (pharmacist offer to counsel required). Does not include reporting requirements from participating pharmacies (i.e. dispensing statistics). Reach out to Medicaid program to identify types of naloxone covered.

43 Additional ConsiderationsProvide specific statutory language authorizing creation of prescription at pharmacy for billing purposes. Considering evaluation metrics such as optional surveys or looking at Medicaid reimbursement data. Monitor pharmacies for compliance with training requirements. Ensure treatment referral resources are available at the pharmacy.

44 Further Expansion of Naloxone Access in OhioGuidance document for hospitals providing upon discharge for unintentional drug poisoning: SB 319: Permitting non-patient specific naloxone to be stored and administered in the event of an emergency. Settings include: homeless shelters, halfway houses, community correction facilities.

45 Contact Cameron J. McNamee Director of Policy and Communications77 South High Street, 17th Floor, Columbus, Ohio 43215 T: (614)   |  F: (614)