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Governor's Conference Wyoming State Board of Pharmacy Update on Prescription Drugs and Opioids in Wyoming May 25, 2017 Lisa V. Hunt, RPh, Chief Compliance Officer Wyoming State Board of Pharmacy 1 Conflict of Interest I have no actual or potential conflict of interest to declare regarding this presentation 2 What Does the Board do? Licensing/Disciplinary Actions/Rules Inspections/Every pharmacy at least annually, some CSR for CS security Investigations of Complaints/Referrals, BOM, BON, DEA, DCI, Office of Civil Rights, …http://pharmacyboard.state.wy.us/Complaint.aspx Information/Education, …WORx 3 Why? Protect the public Abuse/Misuse & Drug overdose death rates Keep current with changing federal and state laws 4 Why? – Some People Take Rx Drugs and Drive 2014 study found 10 million people drove in the last year while using illicit drugs1 “A 2010 nationwide study of fatal crashes found: 46.5 % of drivers who tested positive for drugs had used a Rx The most common prescription drugs found were: drug, “alprazolam (Xanax®) 12.1% hydrocodone (Vicodin®) 11.1% 36.9 % used marijuana, and oxycodone (OxyContin®) 10.2% 9.8 % used cocaine. diazepam (Valium®) 8.4%2 1. 2. 5 2014 National Survey on Drug Use and Health (NSDUH), Wilson, 2010 http://www.drugabuse.gov/publications/drugfacts/druggeddriving;- David Wills Rx Abuse Update CDC Statistics U.S. Drug overdose death rate increased from: US deaths: 12.3/100,000 in 2010 to 16.3/100,000 in 2015 2014: 47,055 to 2015: 52,404 Of these deaths, 63.1% involved an opioid, driven by heroin and synthetic opioids other than methadone Natural/semisynthetic opioids deaths up 2.6% Heroin deaths up 20.6% Synthetic opioids other than methadone up by 72.2 % 6 Natural opioid analgesics, including morphine and codeine, and semi-synthetic opioid analgesics, including drugs such as oxycodone, hydrocodone, hydromorphone, and oxymorphone; Methadone, a synthetic opioid; Synthetic opioid analgesics other than methadone, including drugs such as tramadol and fentanyl; and Heroin, an illicit (illegally-made) opioid synthesized from morphine that can be a white or brown powder, or a black sticky substance. 7 Centers for Disease Control (cdc.gov/mmwr) Wyoming has had a decrease in the number of drug overdose deaths from 2013 to 2015 2013: 98 WY 846 CO 117 NE 55 SD 137 MT 594 UT 207 ID 2014: 109 WY 899 CO 125 NE 63 SD 125 MT 603 UT 212 ID 2015: 96 WY 869 CO 126 NE 65 SD 138 MT 646 UT 218 ID Source: National vital Statistics System, Mortality file using the ICD-10 classification, underlying cause of death codes X40-X44, X60-X64, X85 and Y10-Y14. 8 What has the BOP done? New Rules/Education/WORx Updates Partial filling for Schedule II medications now Allows for periods of longer than 72 hours (CARA of 2016) Reduces amount of drugs in home or on hand Allows for less without voiding the Rx & requiring a new office visit Studies show sources of abused Rx drugs are diverse but include “stealing from grandma’s medicine cabinet” and “doctor shopping”1 Continue inspections, investigations, and disciplinary actions 1. Mechanisms of Prescription Drug Diversion Among Drug-Involved Club- and Street-Based Populations; Authors James A. Inciardi PhD,9 Hilary L. Surratt PhD, Steven P. Kurtz PhD,Theodore J. Cicero PhD, 1 February 2007, DOI: 10.1111/j.1526-4637.2006.00255.x W.S. 35-7-1033 “doctor shopping” “…[U]nlawful for any person…[to:] […obtain a prescription for, any controlled substance by misrepresentation, …includes but is not limited to: (A) Failing to disclose to a practitioner that the person has received...[a] prescription for a controlled substance from another source within the prior thirty (30) days; (B) Alteration or forgery… (C) The use of a false name or address 10 What is WORx? Monitoring tool No diagnostic information Protected patient information/limited access: Dispensing data (data in, data out), Patient’s practitioners & pharmacists Law enforcement only with open investigations. Pharmacy’s must report data by COB on the business day immediately following the day the controlled substance was dispensed (24 hours depending on business hours) Rx not picked up by patient/Returned to stock Reporting errors, incorrect practitioner “dr. shopper”, etc… WORx is not an official record of what occurred! 11 350 300 Total Number of Unsolicited Profiles in Wyoming Since 2009 316 288 250 265 200 196 150 169 100 115 120 50 75 0 2009 2010 2011 2012 2013 2014 75% drop in suspected “doctor shopping” since 2009 2015 2016 12 Why pharmacists? 21 CFR 1306.04(a) Pharmacist is not obligated to fill a prescription just because a prescription is presented by a patient or demanded to be filled for a patient by a practitioner does not mean the pharmacist has to fill it. “A prescription for a controlled substance…must be issued for: a legitimate medical purpose …by [a] practitioner acting in the usual course of his professional practice. The responsibility…for…prescribing…[CS]…is upon the…practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription.” 13 Education: BOP Staff: Mary K. Walker, Executive Director Example report reviews CDC Opiate Prescribing Guidelines, MME’s Importance of patients education on: opiate risks dangers of mixing medications need to keep all providers informed of medications & history proper storage and disposal 14 BOP Education 15 PDMP tools like WORx: 21 states require reports prior to prescribing opioids in some form (1st time) -18 do not Kentucky mandated use in 2012 and there was a 25% reduction in deaths due to opioid overdose Pharmacists and practitioners can use reports to help: identify patients obtaining CS from multiple providers, & calculate the possible MME per day may identify concurrent use of benzodiazepines or other drugs that can potentiate or impact opiate effect 16 Changes to WORx Method of payment (Ins/cash) reported – maybe an indicator of need for drug interaction screens Report/monitoring three non-scheduled drugs: Implementing delegate registration: when notified health care professionals can register/manage their delegates and each will have their own user name and password. Implementing interstate data sharing: gabapentin i.e. NurontinR , cyclobenzaprine i.e. FlexerilR, and naloxone i.e. NarcanR prescriptions dispensed Not immediate/will need the entire legal name of the patient but will be able to get reports from surrounding states. Updating website 17 What is Naloxone Rescue Real Stories from Real People: https://www.narcan.com/ http://www.empr.com/narcan-nasal-spray/drug/34524/ http://www.chaindrugreview.com/cvs-to-provide-narcan-spray-at-discount/ https://www.nytimes.com/2014/06/13/nyregion/anti-overdose-drug-becoming-an-everyday-part-of-police-work.html?_r=0 18 Impact of Opiate Overdose Emergency Treatment to Pharmacists Who may benefit from this? Opiate naïve patients prescribed opiates for the first time Surgery patients who are prescribed high MME’s of opiates Persons who provide care for individuals who self administer opiates (first responders, family member, …) Any persons at risk for an opiate related over dosage Employee risk of exposure 19 Continued… “Ohio SWAT member also needed a trip to the local ER recently while entering a house where the suspect was trying to destroy a large amount of heroin/fentanyl in the toilet. This has prompted drug units to carry nasal naloxone as this is not an isolated problem. Fentanyl is bad enough, but some agencies are experiencing carfentanil, the elephant tranquilizer, mixed in with heroin and/or fentanyl.” https://www.statnews.com/2017/05/16/overdose-officer-fentanyl-east-liverpool/ 20 Impact of Opiate Overdose Emergency Treatment to Pharmacists SF0042 - W.S. 33-24-158 (new) Pharmacist prescribing, rules promulgated with BOM W.S. 35-4-901 (new) Definitions Practitioner or Pharmacist may prescribe without a prescriber-patient relationship to: a person at risk of an opiate overdose a person in a position to assist a person who may encounter a person experiencing an opiate overdose 21 SF0042 Opiate Overdose Emergency Treatment continued… BOM/BON…“Entity” by standing order can establish policy/procedure Report to DOH Voluntary Immunity from liability 22 Immunity for prescribing opiate antagonist W.S. 35-4-906 Personally immune from civil or criminal liability for any act or omission resulting in damage or injury (prescribe or administer) Prescribing an opiate antagonist shall not constitute unprofessional conduct Administration of an opiate antagonist: “act in good faith if appears to be experiencing an opiate related drug overdose” 23 Continued… Pharmacists education: Recognize and respond Administer naloxone Ensure additional medical care Training: 90% of licensed pharmacy staff have already completed opiate/naloxone CE, per BOP CE audit 24 Questions? [email protected] 1 (307) 634-9636 WORXPDMP.com David Wills, MBA, Data Management Specialist 1 (307) 634-9636 Atlantic Associates, PDMP Vendor 1 (800) 539-3370 Pharmacyboard.state.wy.us 25