New Naloxone Regulations & the Importance of Using the PMP Yenh Long PharmD, BCACP Program Administrator Nevada Prescription Monitoring Program May 17, 2017 PRESCRIPTION DRUG ABUSE EPIDEMIC The United States is 5% OF THE WORLD S POPULATION & CONSUMES 80% of the world s supply of opioids 75% of the world s supply of oxycodone 99% of the world s supply of hydrocodone 1 2 Manchikanti L, et al. Pain Physician. 2008 Mar;11(2 Suppl):S63 88. Kenan K, et al. Open Med. 2012 Apr 10;6(2):e41 7 3400 B.C. Earliest reference to opium poppy 1806 Friedrich Serturner isolated morphine from opium 1800 1850 1860 Hypodermic needle. Civil War morphine widely used. Soldiers became addicted Soldier s Disease HISTORICAL TURNING POINTS 1885 Cocaine in everything, Manufactured by Parke Davis, sold in various forms cure for morphine addiction 1898 Heinrich Dreser Bayer began manufacturing heroin as a nonaddictive morphine substitute 1906 FDA created 1900 1914 Harrison Narcotics Tax Act 1924 The Heroin Act importation, manufacturing, possession, medical use of heroin illegal in the U.S 1980 Doctors scared to prescribe opioids opiophobia 1960 s 1970 s Timothy Leary. Nixon s War on Drugs. Controlled Substances Act passed. DEA created. 2000 1990 s and 2000 s Pain under treated. The American Pain Society pain Fifth Vital Sign. JCAHO new standards for pain management. Purdue Fredrick s introduction/aggressive marketing of long acting oral opiates. Pill Mills Doctors prescribing large quantities of CS to people who don t need them medically Doctor Shopping Obtaining prescriptions from multiple prescribers THE PROBLEM 1999 2013 prescription CS prescribed and sold Enough CS prescribed in 2013 to medicate every American Adult Q 4 hours for 1 month!!! 3 http://www.theatlantic.com/sponsored/purdue health/a brief history of opioids/184/ 4 http://www.cdc.gov/vitalsigns/painkilleroverdoses/index.html http://www.cdc.gov/drugoverdose/epidemic/providers.html THE CONSEQUENCE OVERDOSE DEATHS IN NEVADA 2 nd highest for hydrocodone prescriptions (ARCOS) 2 nd highest for oxycodone prescriptions (ARCOS) 4 th highest for methadone prescriptions (ARCOS) 7 th highest for codeine prescriptions (ARCOS) ***In 2015, Nevada had 316 deaths from prescription opioid overdoses*** 5 http://www.cdc.gov/drugoverdose/data/index.html http://dpbh.nv.gov/uploadedfiles/dpbhnvgov/content/programs/clinicalsapta/state%20of%20nevada%20plan%20to%20reduce%20prescription%20drug%20abuse.pdf. 6 http://www.deadiversion.usdoj.gov/arcos/retail_drug_summary/2015/2015_rpt5.pdf http://www.pdmpassist.org/pdf/rx_opioids_overdose_death_rates_table.pdf 1
1999 2015 AVERAGE DEATH RATES FOR DRUG OVERDOSES PMP DATABASE Computerized program to track CS prescriptions Pharmacies, dispensing practitioners transmit data daily Accessible 24/7 through a secure website Prescribers and dispensers request patient reports Prescription Monitoring Program Pharmacies HealthCare Providers Deaths highest in: 1. New Mexico: 21.5 deaths 2. West Virginia: 21.4 deaths 3. Utah: 18.3 deaths Healthcare Licensure Board Law Enforcement 4. Nevada: 7 18.2 deaths http://www.pdmpassist.org/pdf/all_drug_overdose_death_rates_1999_2015_set.pdf 8 http://www.cdc.gov/drugoverdose/pdmp/index.html REGISTER FOR PMP ACCESS DELEGATE REGISTERING FOR PMP ACCESS Go to https://nevada.pmpaware.net 1. Click Create an Account 2. Input your email and password, click Save and Continue 3. On the screen that says Select Your User Roles, click on the Healthcare Professional drop down arrow, select your role, click Save and Continue 4. Complete required Personal and Employer information 5. Complete and return the HealthCare Professional Certification Statement 6. Verify your email by clicking on a link contained in an email from "No Reply PMP Aware". This email may be in your junk or spam folder. Go to https://nevada.pmpaware.net 1. Click Create an Account 2. Input your email and password, click Save and Continue 3. On the screen that says Select Your User Roles, click on the Healthcare Professional drop down arrow, select Prescriber Delegate- Unlicensed, click Save and Continue 4. Complete required Personal, Employer, and Supervisor information 5. Complete and return the HealthCare Professional Certification Statement 6. Verify your email by clicking on a link contained in an email from "No Reply PMP Aware". This email may be in your junk or spam folder. 9 10 7. Supervisor (prescriber) will have to approve the delegate. They need to log into their PMP account, click Delegate Management, select the name of the delegate and click Approve. 1 2 PATIENT JOE JONES 3 Patient PMP Search 1. Click RxSearch 2. Click Patient Request 3. Type in patient First and Last Name 4. System will automatically query 1 year of information 5. Click I agree to the terms of the acknowledgement and click Search Joe Jones Joe Jones Joe Jones Joe Samuel Jones Joe S. Jones Joseph Jones 4 11 5 12 2
Joe Jones DOB: 06/01/1980 Created On: 05/10/2017 PATIENT JOHN SMITH John Smith John Smith John Smith John Smith 11 RXs for tramadol January 2017 13 14 John Smith DOB: 01/01/1980 Created On: 05/10/2017 PATIENT BETTY SUE 12 RXs for CS November 2015 15 16 Requests History 1 2 Shows all the pts you or your delegate queried in the PMP 1. Click RxSearch 1 2. Click Requests History 2 4 Creating a Self-Query 1. Click RxSearch 3 2. Click MyRX 3. Type in time frame for which you want to query 4. Choose the DEA# you want to query 5. Click Search 17 18 5 3
MyRX EXAMPLE NEVADA LEGISLATURE 78 th (2015) SESSION 19 20 SENATE BILL 459 Signed into law May 5, 2015 Effective October 1, 2015 SENATE BILL 459 Two topics: 1. Mandatory use of the PMP 2. Good Samaritan Drug Overdose Act 21 22 MANDATORY USE OF THE PMP A practitioner shall, before prescribing a CS listed in schedule II, III or IV, obtain and review the patient s PMP report if: a. The patient is a new patient of the practitioner; OR b. The prescription is for more than 7 days supply and is part of a new course of treatment for an existing patient. The practitioner shall review the PMP report to assess whether the CS prescription is medically necessary Review may not be delegated, but accessing the database to obtain the report may be delegated to staff 23 24 4
NUMBER OF PRESCRIBERS REGISTERED WITH PMP Licensing Board # of Licensees from each Board* # of Registered PMP Users before Oct 01, 2015 % of Licensees Registered # of Registered PMP Users as of Nov 01, 2016 % of Licensees Registered ** Dental 1576 1330 84.4% 1392 88.3% Nursing 1116 605 54.2% 1124 NA Podiatry 115 8 7% 27 23.5% DO 673 425 63.2% 591 87.8% MD 5072 3057 60% 4238 83.5% Optometry 429 115 26.8% 115 26.8% NUMBER OF PRESCRIBERS USING THE PMP Licensing Board # of Licensees who Searched the PMP in 2016** # of PMP Searches in 2016 Performed by the Licensees Dental 53 4,860 3.8% Nursing 102 30,278 9.1% Podiatry 1 106 3.7% DO 63 51,676 10.7% MD 635 522,411 15% Optometry 1 2 0.2% % of Licensees who are registered and using the PMP in 2016* * These numbers were provided to the PMP from the individual boards on 04/2016 or were taken from the individual board s website. ** Some boards will never reach 100%, the reason is because there are some practitioners who are licensed to practice, and have a controlled substance registration number, but are not writing prescriptions for controlled substances. This is especially true for those who have an optometry or podiatry license. 25 * These numbers were provided to the PMP from the individual boards on 04/2016 or were taken from the individual board s website. ** The number reflects the number of PMP users, based on their license type, who created at least one search in the PMP in 2016. 26 MANDATORY USE OF THE PMP A practitioner who does not use the PMP as mandated: PMP MAKING A DIFFERENCE a. Is not guilty of a misdemeanor b. May be subject to professional discipline if their licensing board determines that the violation was intentional 27 28 http://www.cdc.gov/drugoverdose/policy/successes.html RX drug, a.k.a Narcan WHAT IS NALOXONE? Mechanism of action: opioid antagonist Route: IV, IM, SC (0.4mg/ml), INL (2 4mg/0.1ml) Onset: 2 5 min depending on route Duration: 30 60 min depending on route Dosage (adults): initial dose 0.4 2mg (every 2 3 min up to 10mg) until improvement in respiratory function. Repeat doses may be required within 30 60 min How supplied: milliliter vials, auto injector, nasal spray GOOD SAMARITAN DRUG OVERDOSE ACT Establishes 4 channels a patient may obtain/receive an opioid antagonist (OA) 1. Law enforcement officers may possess and administer an OA 2. Prescribers may prescribe an OA to a person other than the patient such as a family member/friend/other person 3. Unlicensed person or entity may store and/or dispense an OA without charge or compensation under a standing order from a authorized prescriber 4. Pharmacists may dispense an OA under a pharmacy standardized procedure or a physician written protocol without RX 29 30 5
NALOXONE REGULATION PHARMACY STANDARDIZED PROCEDURE Pharmacy written standardized procedures allowing a registered pharmacist to furnish an OA, must include: 1. A restriction that the pharmacist will not delegate their authority to furnish an OA (i.e. delegating to pharmacy technician) 2. Counseling points a pharmacist must provide to a OA recipient: a) Recognize, prevent, and respond to opioid related drug overdose; b) Methods for the safe administration of OA; c) Side effects and adverse events related to the administration of an OA; d) Importance of seeking emergency medical assistance even after the administration of an OA; e) The immunity from certain civil or criminal liabilities for seeking medical assistance for a person experiencing an opioid related overdose NALOXONE REGULATION PHYSICIAN WRITTEN PROTOCOL A physician may establish a written protocol authorizing a registered pharmacist to furnish an OA, which must include: 1. Name of physician providing authorization; 2. OA to be furnished; 3. Procedure for furnishing the OA; 4. Procedure for the annual review of the protocol and its operation by the physician and documentation of the review; 5. A statement that the OA will be furnished by the pharmacist in accordance with all applicable federal, state, and local laws; 6. Signature of the physician providing authorization; 7. Time period for which the protocols is effective; 8. Other limitations set my physician (i.e. age restrictions) NALOXONE REGULATION PHYSICIAN WRITTEN PROTOCOL The physician authorizing a registered pharmacist to furnish an OA by establishing a written protocol shall: Be readily accessible to the pharmacist furnishing the OA or to the recipient of the OA for consultation, assistance, or direction NALOXONE REGULATION CE REQUIREMENT A pharmacist shall, before furnishing an OA under either the standardized procedure or physician written protocol, complete at least 1 CE on the use of an OA and the counseling of a recipient of an OA GOOD SAMARITAN DRUG OVERDOSE ACT Duty to Prescribe or Dispense? GOOD SAMARITAN DRUG OVERDOSE ACT Built in protection from liability SB 459 does not create a duty to prescribe or dispense an OA A prescriber who declines to prescribe or a pharmacist who declines to dispense an OA for any reason is immune from criminal, civil and administrative proceedings A person who, acting in good faith and with reasonable care, prescribes or dispenses [or administers] an opioid antagonist pursuant to subsection 1, is not subject to any criminal or civil liability or any professional disciplinary action for: (a) Such prescribing or dispensing; or (b) Any outcomes that result from the eventual administration of the opioid antagonist. 35 36 6
GOOD SAMARITAN DRUG OVERDOSE ACT Immunity for Good Samaritans Provides immunity to persons who seek medical assistance for themselves or for another person experiencing a drug or alcohol overdose That person may not be arrested, charged, prosecuted or convicted or have his or her property subject to forfeiture. SENATE BILL 114 They are immune to prosecution if the evidence that support their prosecution is a result of the person s seeking medical assistance 37 38 SENATE BILL 114 Extends direct access of the PMP to: Occupational licensing boards Qualifying NV law enforcement officers Board of Pharmacy reports suspected fraudulent or illegal activities to law enforcement (Nevada Division of Investigation (NDI)) and licensing boards (NRS 453.1545(5)) NRS 453.391 NRS 453.391 Unlawful taking or obtaining of controlled substance or prescription. A person shall not: While undergoing treatment and being supplied with any CS prescribed by a practitioner, knowingly obtain CS prescribed by another practitioner without disclosing this fact to the second practitioner. 39 40 HOW ARE THESE NEW LAWS ENFORCED/IMPLEMENTED? Harold Rogers Grant Compliance Coordinator Notifies licensing boards when prescribers are not complying with SB 459 (not registered/obtaining/reviewing PMP reports) Report suspected doctor shoppers to NDI, licensing boards, prescribers, and pharmacies DOCTOR SHOPPING BEHAVIORS Multiple prescribers Multiple pharmacies High drug quantities Switching back and fourth between different types of payment Drug combinations (hydrocodone/carisoprodol/alprazolam) Duplicate/similar therapies (zolpidem/temazepam) Overlapping written and filled dates Unsolicited Patient Reports 41 42 7
UNSOLICITED REPORTS TO LICENSING BOARDS Informs licensing boards possible doctor shoppers, names of licensees involved in the pt s care Reviews SB 459 provides names of licensees not registered with the PMP, those who never queried the pt in the PMP EXAMPLE OF A LICENSING BOARD UNSOLICITED REPORT Licensing board SHALL NOT interpret report as a requirement to conduct an investigation or take action against a practitioner May use the information to alert the practitioner that the pt may be fraudulently obtaining a CS, or to determine whether a practitioner is engaged in unlawful or unprofessional conduct (NRS 453.164(3b)) 43 44 UNSOLICITED REPORTS TO PRESCRIBERS & PHARMACIES Not intended to tell practitioners how to practice Does not mean practitioner is under investigation or in trouble Informs practitioners of possible doctor shoppers Reviews SB 459 requirements Provides PMP registration instructions for those not registered EXAMPLE OF A PRESCRIBER UNSOLICITED REPORT 45 46 47 WHAT SHOULD HAPPEN IF YOU RECEIVE AN UNSOLICITED REPORT? Please do not fire the patient Are prescriptions fraudulent? 1.Fill out hotline report http://bop.nv.gov/forms/forms/ 2. Report to Law Enforcement Rx Fraud Hotline: 775 334 6256 RX Fraud Email: RXFraud@reno.gov Addiction Treatment Programs http://healthiernv.org/resource list/ Yes Review Unsolicited Report No Consider continuing treatment Pain Management Specialists http://med.unr.edu/documents/unsom/statewi de/echo/clinics/pain management/ Nevada%20Resources%20Opioid%20Issues.pdf Yes Does pt have a CS abuse problem? Refer to: Yes Discuss issue with patient Taper down/off Pre Criminal Intervention Program Refer to Pre criminal Intervention Program Officer at 775 850 1469 Number of prescribers who prescribed above a specific MME/d threshold categorized according to their respective boards for year 2015* The total number of RXs with MME/d more than 0 filled in 2015 is 4,402,539 The minimum value of MME/d prescribed in 2015 is 0.05 and the maximum is 720.0 The mean value of MME/d prescribed in 2015 is 12.09 and median is 5.0 About 75% of RXs written are of MME 10.0/d, and 99% of RXs written are of MME 120.0/d The total number of RXs with MME/d equal to 720.0 is 7,409 MME/d Threshold MD Board** DO Board** Nursing Board** Dental Board** Podiatry Board** Others** Total 90 1364 206 237 8 4 125 1951 150 1199 186 212 6 2 110 1722 300 1022 154 180 2 1 87 1454 500 777 122 144 1 0 62 1114 720 537 76 104 1 0 34 760 *These are approximately estimated numbers generated from the dispensation data in the year 2015 in the state of Nevada. **The segmentation or categorization of prescribers into their respective boards is based on matching the names from the lists provided by the boards. Errors can be expected. 48 8
CDC GUIDELINE FOR PRESCIBING FOR CHRONIC PAIN Recommendations for prescribing opioids for patients 18 in primary care settings for chronic pain ( 3 months) Recommendations not for patients receiving active cancer treatment, in palliative or end of life care 12 recommendations 49 Deborah Dowell, et al. MMWR Recommendations and Reports. March 18, 2016. 65(1);1 49. https://emergency.cdc.gov/coca/ppt/2016/slide_guidelineprescribingopioids_062216.pdf 50 https://www.cdc.gov/drugoverdose/pdf/guidelines_factsheet a.pdf 51 https://www.cdc.gov/drugoverdose/pdf/guidelines_factsheet a.pdf 52 https://www.cdc.gov/drugoverdose/pdf/guidelines_factsheet a.pdf ERRORS IN THE PMP? Concerns regarding accuracy of information in the PMP Database ACCURACY OF PMP DATA Database is only as good as the information put into it by dispensers PMP actively working with prescribers, pharmacists, pharmacies to improve accuracy Board of Pharmacy hired a Project Analyst tasked with auditing the PMP for information accuracy 53 54 9
ACCURACY OF PMP DATA REQUIREMENTS ON A CS PRESCRIPTION NAC 453.440 Prescription Contents 1. Each RX for a CS, other than an oral or electronically transmitted RX, must contain: a) Name of the prescribing practitioner; b) Address of the prescribing practitioner if not immediate available to the pharmacist or pharmaceutical technician; c) Handwritten signature of the prescribing practitioner in nonerasable ink; d) Date the RX was issued e) Full name of the patient f) Address of the patient if not immediately available to the pharmacist or pharmaceutical technician g) Name, strength and quantity of the drug or drugs prescribed; h) Direction for use; i) Classification of the license of the prescribing practitioner; and j) Registration number from the Drug Enforcement Administration of the prescribing practitioner 55 56 Email: CONTACT INFORMATION Licensing questions: pharmacy@pharmacy.nv.gov Law questions: pedwards@pharmacy.nv.gov PMP questions: pmp@pharmacy.nv.gov Other general questions: lpinson@pharmacy.nv.gov Board tele: (775) 850 1440 PMP tele: (775) 687 5694 57 58 10