bureau of narcotic enforcement update nurse practitioner association syracuse chapter june 13, 2014
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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. - PowerPoint PPT PresentationTRANSCRIPT
Bureau of Narcotic Enforcement Update
Nurse Practitioner AssociationSyracuse Chapter
June 13, 20141
Anita L. Murray, R.Ph.
Assistant Director Bureau of Narcotic Enforcement
2
Conflict of Interest
No conflict of interest to report
3
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
4
Pre-Test Q1: The I-STOP legislation requires:
A. A pharmacist to access the Prescription Monitoring Program prior to dispensing a controlled substance
B. A practitioner to access the Prescription Monitoring Program prior to prescribing a controlled substance in Schedules II-V
C. A practitioner to access the Prescription Monitoring Program prior to prescribing a controlled substance in Schedules II-IV
D. A and C are correctE. None of the above
5
Pre-Test Q2: Data presented in NY’s online Prescription Monitoring
Program Registry is obtained from:A. Pharmacy data
submissions to BNEB. The DEA’s ARCOS
dataC. Office of Professional
Medical Conduct D. NYS Office of Health
Insurance Programs— Medicaid
E. All of the above
6
Pre-Test Q3: Which of the following are true:
A. The Prescription Drug Reform Act requires a face to face office visit every time a prescription for a controlled substance is written
B. The PMP Registry provides 6 months of patient-specific controlled substance dispensed prescription information
C. The PMP Registry “red flags” my patient and alerts me
D. The use of the PMP Registry is only required when prescribing Schedule II Controlled Substances
7
Pre-Test Q4: New regulations related to hypodermic needles and syringes allow
for:A. Electronic prescribing of
needles and syringesB. Oral prescriptions
communicated by a practitioner or their employee with no follow-up prescription required
C. Quantity greater than 100 on an oral prescription
D. Refills are allowedE. All of the above
8
Pre-Test Q5: Syringes containing controlled
substances must follow all laws, rules and regulations
related to controlled substances.
A. TrueB. False
9
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.
10
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… 11
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
12
13
Motor Vehicle Traffic, Poisoning, and Drug Poisoning (Overdose) Death Rates
United States, 1980–2010
NCHS Data Brief, December, 2011. Updated with 2009 and 2010 mortality data.
1980 1982 1984 1986 1988 1990 1992 1994 1996 1998 2000 2002 2004 2006 2008 20100
5
10
15
20
25
Motor Vehicle Traffic Poisoning Drug Poisoning (Overdose)
Year
Dea
ths
per
100,
000
popu
lati
on
14
Overdose deaths of all intents by major drug type, U.S., 1999-2009
02,0004,0006,0008,000
10,00012,00014,00016,00018,000
99 00 01 02 03 04 05 06 07 08 09
Num
ber
of d
eath
s
Source: National Vital Statistics System
Opioid analgesic
Heroin
Cocaine
15
16
Unintentional overdose deaths involving opioid analgesics parallel per
capita sales of opioid analgesics in morphine equivalents by year, U.S.,
1997-2007
0
100
200
300
400
500
600
700
800
0
2000
4000
6000
8000
10000
12000
14000
'97 '98 '99 '00 '01 '02 '03 '04 '05 '06 '07
Source: National Vital Statistics System, multiple cause of death dataset, and DEA ARCOS* 2007 opioid sales figure is preliminary.
Number of Deaths Opioid sales
(mg/person)
*
1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 20100
1
2
3
4
5
6
7
8
Opioid Sales KG/10,000 Opioid Deaths/100,000Opioid Treatment Admissions/10,000
Year
Rate
Rates of Opioid Sales, OD Deaths, and Treatment, 1999–2010
CDC. MMWR 2011 17
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
Drug Overdose Deaths
18
Recent National Trends Those at Risk
SexFrom 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
19
Recent National Trends Those at Risk
EthnicityFrom 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 20
Recent National Trends Those at Risk
Age GroupsSince 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 % increase CDC/NCHS Data Brief,
December 2012
21
Primary non-heroin opiates/synthetics admission rates, by State (per 100,000 population aged 12 and over)
22
Primary non-heroin opiates/synthetics admission rates, by State (per 100,000 population aged 12 and over)
23
Primary non-heroin opiates/synthetics admission rates, by State (per 100,000 population aged 12 and over)
24
Primary non-heroin opiates/synthetics admission rates, by State (per 100,000 population aged 12 and over)
25
Primary non-heroin opiates/synthetics admission rates, by State (per 100,000 population aged 12 and over)
26
Primary non-heroin opiates/synthetics admission rates, by State (per 100,000 population aged 12 and over)
27
New York State Trends
28
29
30
Deaths Involving Opioid Analgesics
in New York State 2003-2012
31
2003 2004 2005 2006 2007 2008 2009 2010 2011 20120
100200300400500600700800900
1000
Poisonings Involving Opioid Analgesics
Year
Num
ber
of D
eath
s
32
33
34
Part A: I-STOP
Part B: Electronic Prescribing
Part C: Controlled Substance Schedule Changes
Part D: 3309 Work Group
Part E: Safe Disposal Program
Prescription Drug Reform Act
(more commonly known as I-STOP)
35
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 37
ExceptionsPractitioner administering a CSPrescribed 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)
Hospice38
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
39
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
40
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.
PMP Searches by Profession8/27/13—4/13/14
42
69%
12%
8%8% 2%
MedicineNurse PractitionersPharmacist
Additional Access to PMP Data
Pharmacists Attorney General’s Office County Health Departments
engaged in public health research or education
Medical Examiner/Coroners Patients
43
PMP Data SubmissionEffective August 27, 2013,
pharmacies are required to submit prescription data to BNE within 24 hours
“Real Time” defined in PMP regulations
44
PMP Data SubmissionAfter 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.
45
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
46
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
47
Electronic Prescribing
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
49
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
50
Electronic Prescribing for Controlled
Substances (EPCS) Prescribing and dispensing
application must meet security standards set forth by the DEA for EPCS
Certified computer application must be registered with BNE
Two-factor authentication for prescribers to ensure prescription integrity and non-repudiation
http://www.deadiversion.usdoj.gov/fed_regs/rules/2010/fr0331.pdf
51
EPCS Exceptions Technological or electrical failure Use of EPCS would impact the patient’s
medical condition (up to 5 day supply) Issued by a practitioner to be dispensed
outside of New York State Veterinarians Practitioners who have received a waiver
from the Department of Health
52
Waivers Practitioners may apply for a waiver
from the requirement to electronically prescribe controlled substances
Waivers will be granted upon a proper showing of economic hardship, technological limitations outside of the practitioner’s control or other exceptional circumstances
By statute, waivers are good for one year, after which a practitioner may apply for a renewal
53
Changes to Controlled Substance SchedulesPublic Health Law §3306
Changes to SchedulesEffective February 23, 2013
All products containing hydrocodone were placed on Schedule II
Tramadol was placed on Schedule IV 55
56
1Q09 2Q09 3Q09 4Q09 1Q10 2Q10 3Q10 4Q10 1Q11 2Q11 3Q11 4Q11 1Q12 2Q12 3Q12 4Q12 1Q13 2Q13 3Q13 4Q13 1Q140
200,000
400,000
600,000
800,000
1,000,000
1,200,000
1,400,000
Commonly Prescribed Pain Re-lievers
Codeine 3 Hydrocodone OxycodonePregabalin Tramadol
Prescription Pain Medication Awareness Program
Workgroup Established pursuant to PHL §3309-
a Comprised of practitioners,
pharmacists, consumer advocates, and law enforcement agencies
Tasked with helping DOH educate practitioners, pharmacists, and the public about controlled substance medications
58
Workgroup Recommended 2 hours of
required continuing education for practitioners and pharmacists on pain management issues
Provided guidance with implementation of I-STOP;development of new PMP Registry; and
regulations
59
Educational Materials
60
Safe Disposal Program
62
Safe Disposal Consumers need a means to safely
dispose of prescription medications including controlled substances
Safe disposal sites established with local police departments
New law in NY Article 33, Section 3343-b—Important to note disposal must be in accordance with federal law. Federal rules yet to be finalized
63
Medication Drop Box Map
64
Safe DisposalMedication Drop Box Located in Saratoga County• Town of Waterford Public Safety
65 Broad StreetWaterford, NY 12188
Medication Drop Box Located in Rensselaer County• North Greenbush Police Department
133 Blooming Grove RoadNorth Greenbush, NY 12180-8553
65
Recent Part 80 Regulations
Electronic Prescribing of Controlled Substances
Limited English Proficiency (LEP)
Prescription Monitoring Program (PMP)
Hypodermic Needles and Syringes
66
Hypodermic Needles and Syringes
Regulations finalized October 9, 2013
Permits electronic prescribing of needles and syringes
If syringe contains a controlled substance, must follow all regulations related to dispensing of a controlled substance 67
Hypodermic Needles and Syringes Regulations
Oral prescriptions: Removed quantity limit of 100 No follow-up prescription required
No longer only in an emergent situation
Practitioner or his or her agent may communicate the oral order
Reduce oral prescription to an electronic record
68
Hypodermic Needles and Syringes Regulations
Authorizes a pharmacist to:Endorse a pharmacy’s e-prescription with his/her electronic signature and other required information
Pharmacists may now transfer one authorized refill (non-controlled) at a time—follow SBOP rules on transfers
69
Hypodermic Needles and Syringes Regulations
Allows the dispensing record to be made and kept in electronic form, as is currently the case for non-controlled substance prescriptions
Authorizes a pharmacist to dispense hypodermic syringes and needles to patients in a Residential Health Care Facility (RHCF) pursuant to a patient specific prescription form as permitted under Education Law 6810(7)(b)
70
Hypodermic Needles and Syringes Regulations
Hypodermic needles and syringe prescriptions valid for 2 years
Updated destruction/disposal of needles and syringes to be consistent with universal precautions
71
Post-Test Q1: The I-STOP legislation requires:
A. A pharmacist to access the Prescription Monitoring Program prior to dispensing a controlled substance
B. A practitioner to access the Prescription Monitoring Program prior to prescribing a controlled substance in Schedules II-V
C. A practitioner to access the Prescription Monitoring Program prior to prescribing a controlled substance in Schedules II-IV
D. A and C are correctE. None of the above
72
Post-Test Q2: Data presented in NY’s online Prescription Monitoring
Program Registry is obtained from:A. Pharmacy data
submissions to BNEB. The DEA’s ARCOS
dataC. Office of Professional
Medical Conduct D. NYS Office of Health
Insurance Programs— Medicaid
E. All of the above
73
Post-Test Q3: Which of the following are true:
A. The Prescription Drug Reform Act requires a face to face office visit every time a prescription for a controlled substance is written
B. The PMP Registry provides 6 months of patient-specific controlled substance dispensed prescription information
C. The PMP Registry “red flags” my patient and alerts me
D. The use of the PMP Registry is only required when prescribing Schedule II Controlled Substances
74
Post-Test Q4: New regulations related to hypodermic needles and syringes
allow for:A. Electronic prescribing of
needles and syringesB. Oral prescriptions
communicated by a practitioner or their employee with no follow-up prescription required
C. Quantity greater than 100 on an oral prescription
D. Refills are allowedE. All of the above
75
Post-Test Q5: Syringes containing controlled
substances must follow all laws, rules and regulations
related to controlled substances.
A. TrueB. False
76
Bureau of Narcotic Enforcementwww.nyhealth.gov
Riverview Center150 Broadway
Albany, NY 12204Phone: (866)- 811-7957
E-mail: [email protected]
Regional Offices:NYC: (212) 417-4103
Buffalo: (716) 847-4532Syracuse: (315) 477-8459Rochester: (585) 423-8043
77