Download Hypodermic Needles and Syringes Regulations

Bureau of Narcotic Enforcement
Update
Nurse Practitioner Association
Syracuse Chapter
June 13, 2014
1
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.
B.
C.
D.
E.
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
5
Pre-Test Q2: Data presented in NY’s online
Prescription Monitoring Program Registry is
obtained from:
A.
B.
C.
D.
E.
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
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.
B.
C.
D.
E.
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
8
Pre-Test Q5: Syringes containing
controlled substances must follow all
laws, rules and regulations related to
controlled substances.
A.
B.
True
False
9
Bureau of Narcotic Enforcement
BNE has three distinct sections

Narcotic Investigations



Regulatory Compliance


Conducts investigations, inspections, outreach;
Partners with law enforcement and regulatory agencies.
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
Motor Vehicle Traffic, Poisoning, and Drug
Poisoning (Overdose) Death Rates
United States, 1980–2010
Motor Vehicle Traffic
Poisoning
Drug Poisoning (Overdose)
Deaths per 100,000 population
25
20
15
10
5
0
1980
1982
1984
1986
1988
1990
1992
1994
1996
1998
2000
2002
2004
2006
2008
2010
Year
NCHS Data Brief, December, 2011. Updated with 2009 and 2010 mortality data.
13
Overdose deaths of all intents by
major drug type, U.S., 1999-2009
18,000
Opioid
analgesic
Number of deaths
16,000
14,000
12,000
10,000
Cocaine
8,000
6,000
4,000
Heroin
2,000
0
99
00
01
02
03
04
05
06
07
08
09
Source: National Vital Statistics System
14
15
Unintentional overdose deaths involving opioid
analgesics parallel per capita sales of opioid
analgesics in morphine equivalents by year, U.S.,
1997-2007
14000
*
800
12000
700
10000
600
8000
500
Number of
6000
Opioid sales
(mg/person)
Deaths
400
300
4000
200
2000
100
0
0
'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.
16
8
Rates of Opioid Sales, OD Deaths, and Treatment, 1999–2010
Opioid Sales KG/10,000
7
Opioid Deaths/100,000
Opioid Treatment Admissions/10,000
6
Rate
5
4
3
2
1
0
1999
CDC. MMWR 2011
2000
2001
2002
2003
2004
2005
Year
2006
2007
2008
2009
2010
17
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
18
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
19
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
20
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 agespecific 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
1000
900
800
Number of Deaths
700
600
500
400
300
200
100
0
2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Year
Poisonings Involving Opioid Analgesics
31
32
33
34
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
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
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
38
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 Profession
8/27/13—4/13/14
3%
8%
8%
12%
69%
Medicine
Nurse Practitioners
Pharmacist
Registered Physician Assistant
42
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 Submission
 Effective
August 27, 2013, pharmacies
are required to submit prescription
data to BNE within 24 hours
 “Real
Time” defined in PMP
regulations
44
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.
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 nonrepudiation
http://www.deadiversion.usdoj.gov/fed_regs/r
ules/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 Schedules
Public Health Law §3306
Changes to Schedules
Effective February 23, 2013

All products containing hydrocodone
were placed on Schedule II

Tramadol was placed on Schedule IV
55
Commonly Prescribed Pain Relievers
1,400,000
1,200,000
1,000,000
800,000
600,000
400,000
200,000
0
1Q09 2Q09 3Q09 4Q09 1Q10 2Q10 3Q10 4Q10 1Q11 2Q11 3Q11 4Q11 1Q12 2Q12 3Q12 4Q12 1Q13 2Q13 3Q13 4Q13 1Q14
Codeine 3
Hydrocodone
Oxycodone
Pregabalin
Tramadol
56
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 Disposal
Medication Drop Box Located in Saratoga County
• Town of Waterford Public Safety
65 Broad Street
Waterford, NY 12188
Medication Drop Box Located in Rensselaer County
• North Greenbush Police Department
133 Blooming Grove Road
North 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.
B.
C.
D.
E.
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
72
Post-Test Q2: Data presented in NY’s online
Prescription Monitoring Program Registry is
obtained from:
A.
B.
C.
D.
E.
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
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.
B.
C.
D.
E.
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
75
Post-Test Q5: Syringes containing
controlled substances must follow all
laws, rules and regulations related to
controlled substances.
A.
B.
True
False
76
Bureau of Narcotic Enforcement
www.nyhealth.gov
Riverview Center
150 Broadway
Albany, NY 12204
Phone: (866)- 811-7957
E-mail: [email protected]
Regional Offices:
NYC: (212) 417-4103
Buffalo: (716) 847-4532
Syracuse: (315) 477-8459
Rochester: (585) 423-8043
77