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Bureau of Narcotic Enforcement Update Nurse Practitioner Association Syracuse Chapter June 13, 2014. Anita L. Murray, R.Ph . Assistant Director Bureau of Narcotic Enforcement. Conflict of Interest. No conflict of interest to report. Learning Objectives.
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Bureau of Narcotic Enforcement Update Nurse Practitioner Association Syracuse Chapter June 13, 2014
Anita L. Murray, R.Ph. Assistant Director Bureau of Narcotic Enforcement
Conflict of Interest No conflict of interest to report
Learning Objectives • Review and understand the opioid abuse problem nationally and in New York State • Review all components of the Prescription Drug Reform Act—Chapter 447 of the Laws of 2012 • Specify recently implemented components of the PMP regulations • Identify the practitioner’s and pharmacist’s role in other new controlled substance regulations, including regulations related to needles and syringes
Pre-Test Q1: The I-STOP legislation requires: • A pharmacist to access the Prescription Monitoring Program prior to dispensing a controlled substance • A practitioner to access the Prescription Monitoring Program prior to prescribing a controlled substance in Schedules II-V • A practitioner to access the Prescription Monitoring Program prior to prescribing a controlled substance in Schedules II-IV • A and C are correct • None of the above
Pre-Test Q2: Data presented in NY’s online Prescription Monitoring Program Registry is obtained from: • Pharmacy data submissions to BNE • The DEA’s ARCOS data • Office of Professional Medical Conduct • NYS Office of Health Insurance Programs— Medicaid • All of the above
Pre-Test Q3: Which of the following are true: • The Prescription Drug Reform Act requires a face to face office visit every time a prescription for a controlled substance is written • The PMP Registry provides 6 months of patient-specific controlled substance dispensed prescription information • The PMP Registry “red flags” my patient and alerts me • The use of the PMP Registry is only required when prescribing Schedule II Controlled Substances
Pre-Test Q4: New regulations related to hypodermic needles and syringes allow for: • Electronic prescribing of needles and syringes • Oral prescriptions communicated by a practitioner or their employee with no follow-up prescription required • Quantity greater than 100 on an oral prescription • Refills are allowed • All of the above
Pre-Test Q5: Syringes containing controlled substances must follow all laws, rules and regulations related to controlled substances. • True • False
Bureau of Narcotic Enforcement BNE has three distinct sections • Narcotic Investigations • Conducts investigations, inspections, outreach; • Partners with law enforcement and regulatory agencies. • Regulatory Compliance • Issues licenses, certifications, and permits. • Public Health Initiatives & Administration • Administers Official Prescription Program, Prescription Monitoring Program, and grants; • Conducts education and outreach; • Helps formulate policy and regulations.
Bureau of Narcotic Enforcement • New York State Controlled Substance Act--Article 33 of the Public Health Law • Purpose of Article 33 • To combat illegal use of and trade in controlled substances; and • To allow legitimate use of controlled substances in health care, including palliative care; veterinary care; research and other uses authorized by this article or other law…
Recent National Trends • Over the past decade, the age-adjusted drug poisoning death rate nearly doubled, from 6.2 per 100,000 population in 2000 to 12.3 per 100,000 in 2010 • The age-adjusted unintentional drug poisoning death rate more than doubled, from 4.1 per 100,000 population in 2000 to 9.7 per 100,000 in 2010 CDC/NCHS Data Brief, December 2012
Motor Vehicle Traffic, Poisoning, and Drug Poisoning (Overdose) Death RatesUnited States, 1980–2010 NCHS Data Brief, December, 2011. Updated with 2009 and 2010 mortality data.
Overdose deaths of all intents by major drug type, U.S., 1999-2009 Opioid analgesic Cocaine Heroin Source: National Vital Statistics System
Unintentional overdose deaths involving opioid analgesics parallel per capita sales of opioid analgesics in morphine equivalents by year, U.S., 1997-2007 * Number of Deaths Opioid sales (mg/person) Source: National Vital Statistics System, multiple cause of death dataset, and DEA ARCOS * 2007 opioid sales figure is preliminary.
Rates of Opioid Sales, OD Deaths, and Treatment, 1999–2010 CDC. MMWR 2011
Drug Overdose Deaths In 2010 there were 38,329 drug overdose deaths in the U.S. 57.7 % (22,134) involved pharmaceuticals; • Opioids-75.2 % (16,651), • Benzodiazepines - 29.4% (6,497), • Antidepressants -17.6% (3,889), and • Antiepileptic and antiparkinsonism- 7.8% (1,717) Source: Pharmaceutical Overdose Deaths, United States 2010; Jones, Mack & Paulozzi; JAMA 2013;309(7):657-659
Recent National Trends Those at Risk • Sex • From 2000 to 2010, drug poisoning death rates increased more than 130 % for females and about 80% for males • In 2010, the age-adjusted rate of drug poisoning deaths for males was 1.5 times that of females CDC/NCHS Data Brief, December 2012
Recent National Trends Those at Risk • Ethnicity • From 2000 to 2010, drug poisoning death rates increased nearly 140% for non-Hispanic whites, compared to an increase of 10% for non-Hispanic blacks CDC/NCHS Data Brief, December 2012
Recent National Trends Those at Risk • Age Groups • Since 2004, the drug poisoning death rate has been highest among 45-54 year olds • From 2009 to 2010, the largest age-specific increase in death rate was among 55-64 year olds, with a nearly 10 % increaseCDC/NCHS Data Brief, December 2012
Primary non-heroin opiates/synthetics admission rates, by State (per 100,000 population aged 12 and over)
Primary non-heroin opiates/synthetics admission rates, by State (per 100,000 population aged 12 and over)
Primary non-heroin opiates/synthetics admission rates, by State (per 100,000 population aged 12 and over)
Primary non-heroin opiates/synthetics admission rates, by State (per 100,000 population aged 12 and over)
Primary non-heroin opiates/synthetics admission rates, by State (per 100,000 population aged 12 and over)
Primary non-heroin opiates/synthetics admission rates, by State (per 100,000 population aged 12 and over)
Deaths Involving Opioid Analgesicsin New York State 2003-2012
Prescription Drug Reform Act(more commonly known as I-STOP) Part A: I-STOP Part B: Electronic Prescribing Part C: Controlled Substance Schedule Changes Part D: 3309 Work Group Part E: Safe Disposal Program
I-STOP “Internet System to Track Over-Prescribing”
Duty to Consult--Practitioners Practitioners must consider their patient’s information presented in the PMP Registry prior to prescribing or dispensing any controlled substance listed in Schedule II, III, or IV The data considered by the practitioner must be obtained from the PMP Registry no more than 24 hours before the prescription is issued
Exceptions • Practitioner administering a CS • Prescribed for use within an institutional dispenser (does not include discharge, therapeutic leave, or other off-premise use) • Prescribed within an ED attached to a general hospital (limited to 5 day supply) • Hospice
Exceptions • Technological failure of PMP or practitioner’s hardware • Practitioner must take reasonable steps to correct the technological failure or limitation • If consulting the PMP Registry would result in a patient’s inability to obtain a prescription in a timely manner, thereby adversely impacting the medical condition of such patient
Exceptions • It is not reasonably possible to access the PMP, no other practitioner/designee may access for practitioner, AND the quantity prescribed is 5 days or less • All three elements must be satisfied. Merely writing a 5 day prescription does not relieve a practitioner from having to check the PMP
PMP Utilization • Old PMP/CSI(2/16/2010 through 6/11/2013) 5,087 users performed 465,639 searches for 202,714 patients. • New PMP (6/12/13 through 8/26/13) 14,191 users performed 282,286 searches for 201,796 patients. • I-STOP(8/27/12 through 4/15/14) 72,651 users performed 10,355,543 searches for 4,388,363 patients.
Additional Access to PMP Data Pharmacists Attorney General’s Office County Health Departments engaged in public health research or education Medical Examiner/Coroners Patients
PMP Data Submission Effective August 27, 2013, pharmacies are required to submit prescription data to BNE within 24 hours “Real Time” defined in PMP regulations
PMP Data Submission After receiving these records, BNE • Screens all records for critical errors; • Rejects any record containing a critical error and notifies the submitter so it can be corrected; • De-duplicates any identical records; • Matches new record to existing patient records; • Presents new record in PMP Registry This process takes about 2 hours from when BNE receives the original record.
FAQ/Common Issues • Why can’t I find my patient’s data in the PMP? • Data entry/submission error, record is awaiting correction, incorrect search terms were entered, prescription was filled out-of-state • Why is the prescriber information is incorrect? • Likely a data entry error
Complaints From Patients • My doctor: • charges me $5 to check PMP; • said I-STOP requires me to come into the office every month to pick up my prescription; • said the PMP and DOH have red-flagged me and won’t let him/her prescribe any medications for me
Official Prescription Program • NY issues forge-proof official prescription forms to all registered practitioners within the State • Over 147,620,300 forms issued in 2012 • Over 141,289,600 issued in 2013
Electronic Prescribing DOH enacted regulations allowing for electronic prescribing of controlled substances (EPCS) in March 27, 2013 Electronic prescribing of controlled and non-controlled substances becomes mandatory for all practitioners as of March 27, 2015