Rpld S21, S3306 schedule II sub (b) 6, amd Pub Health L, generally; amd S6810, Ed L; amd S220.00, Pen L
Enacts the Internet system for tracking over-prescribing (I-STOP) act and creates a prescription monitoring program registry (part A); relates to prescription drug forms, electronic prescribing and language assistance (part B); relates to schedules of controlled substances (part C); relates to continuing education for practitioners and pharmacists in prescription pain medication awareness and the duties of the pain management awareness workgroup (part D); relates to the safe disposal of controlled substances (part E).
NEW YORK STATE ASSEMBLY MEMORANDUM IN SUPPORT OF LEGISLATION submitted in accordance with Assembly Rule III, Sec 1(f)
BILL NUMBER: A10623
SPONSOR: Rules (Cusick) TITLE OF BILL:
AN ACT to amend the public health law, in relation to enacting the
internet system for tracking over-prescribing (I-STOP) act and creating
a prescription monitoring program registry (Part A); to amend the public
health law and the education law, in relation to prescription drug
forms, electronic prescribing and language assistance; and to repeal
section 21 of the public health law, relating thereto (Part B); to amend
the public health law and the penal law, in relation to schedules of
controlled substances; and to repeal certain provisions of the public
health law relating thereto (Part C); to amend the public health law, in
relation to continuing education for practitioners and pharmacists in
prescription pain medication awareness and the duties of the
prescription pain management awareness workgroup (Part D); and to amend
the public health law, in relation to the safe disposal of controlled
substances (Part E)
PURPOSE:
This bill would promote the safe and effective use of prescription drugs
and curb the diversion and abuse of such drugs by: (1) modernizing the
state's Prescription Monitoring Program and enacting the Internet System
for Tracking Over-Prescribing Act; (2) requiring all prescriptions to be
transmitted by electronic means; (3) updating the State's controlled
substance schedules; (4) expanding the duties of the workgroup estab-
lished under the Prescription Pain Medication Awareness Program with
respect to continuing education for practitioners and pharmacists; and
(5) requiring the Department of Health (DOH) to establish a safe
disposal program to facilitate consumer disposal of unused medications.
SUMMARY OF PROVISIONS:
Section 1 of the bill sets forth the legislative intent and findings
explaining the measures taken by the bill to address diversion and abuse
of controlled substances.
Section 2 of the bill provides that each part is a separate component of
the bill with its own effective date.
Section 3 of the bill, which appears after Part E, sets forth a severa-
bility provision.
Section 4 sets forth an overall effective date for the bill.
A. The "Internet System for Tracking Over-Prescribing" (I-STOP) Act
(Part A)
Section 1 of Part A of the bill provides that the bill would enact the
"Internet System for Tracking Over-Prescribing" (I-STOP) Act.
Section 2 of Part A of the bill would add new Public Heath Law (PHL) §
3343-a. New PHL § 3343-a(1) would require the Commissioner of Health to
update the State's existing Prescription Monitoring Program by estab-
lishing and maintaining a system for collecting, monitoring and report-
ing data concerning the prescribing and dispensing of controlled
substances. Known as the Prescription Monitoring Program Registry (PMP
Registry or Registry), the Registry would be secure, easily accessible
by practitioners and pharmacists, and compatible with the electronic
transmission of prescriptions for controlled substances required under
Part B of the bill.
New PHL § 3343-a(2) would require health care practitioners or their
authorized designees to consult the Registry before prescribing or
dispensing any controlled substance listed on Schedule II, III or IV of
PHL § 3306, with certain exceptions.
New PHL § 3343-a(3) would permit pharmacists or their authorized desig-
nees to consult the Registry before dispensing a controlled substance.
New PHL § 3343-a(4) would provide practitioners, pharmacists or their
designees who act reasonably and in good faith immunity from civil
liability arising from any false, incomplete or inaccurate information
submitted to or reported by the Registry or for any resulting failure of
the system to accurately or timely report such information.
New PHL § 3343-a(5) would require the Commissioner of Health to provide
guidance to practitioners and, in consultation with the Commissioner of
Education, to pharmacists and pharmacies, regarding the purposes and
uses of the Registry established by this section.
New PHL § 3343-a(6) would permit individuals to request copies of their
controlled substance history maintained in the Registry and to seek
correction of erroneous information.
New PHL § 3343-a(7) would require DOH to periodically analyze data
contained in the Registry and provide information about potential
violations of law or breaches of professional standards to the appropri-
ate entities.
New PHL § 3343-a(8) would require DOH to seek funding, as appropriate,
from the federal government or other entities to support operation of
the Registry, and to prohibit DOH from specifically imposing fees for
such operation on practitioners, pharmacists, designees or patients.
New PHL § 3343-a(9) would require the Commissioner of Health to promul-
gate rules and regulations necessary to effectuate the provisions of new
PHL § 3343-a.
Section 3 of Part A of the bill would amend PHL § 3333(4) to require
that pharmacies file prescription information with DOH by electronic
means on a real time basis pursuant to DOH regulations, and to authorize
DOH to waive the real time requirement if and to the extent that the
Commissioner of Health finds it warranted, in his or her discretion, due
to a pharmacy's demonstration of economic hardship or other exceptional
circumstance.
Section 4 of Part A of the bill would amend P1-IL § 3371(1)(d), which
currently permits DOH to disclose controlled substances information to a
central registry, to refer instead to the Registry.
Section 4 also would amend PHL § 3371(1)(e), which currently permits DOH
to disclose information about dispensed controlled substances to a prac-
titioner under limited circumstances, so that DOH also could provide
notifications of relevant controlled substance activity and allow prac-
titioners to consult the Registry as required by new PHL § 3343-a.
Section 4 also would add new PHL § 3371(1)(f) to permit DOH to disclose
relevant information about controlled substance activity to pharmacists,
including as permitted by new PHL § 3343-a.
Section 4 also would add new PHL § 3371(1)(g) to permit DOH to disclose
information to the Attorney General's Medicaid Fraud Control Unit, in
furtherance of an investigation of fraud, waste or abuse of the Medicaid
program and pursuant to an agreement with DOH.
Section 4 also would add new PHL § 3371(1)(h) to permit DOH to disclose
information to local health departments for purposes of public research
and education pursuant to an agreement with DOH.
Section 4 also would add new PHL § 3371(1)(i) to permit DOH to disclose
information to medical examiners and coroners.
Section 4 also would add new PHL § 3371(1)(j) to permit DOH to provide
individuals with their controlled substance histories maintained in the
Registry, as permitted by new PHL § 3343-a(6).
Section 5 of Part A of the bill would renumber PHL § 3371(2) and add a
new provision to provide that the Registry may be accessed by practi-
tioners and pharmacists as set forth in new PHL § 3343-a, under terms
and conditions established by DOH as necessary to maintain the security
and confidentiality of the information contained in the Registry.
Section 5 also would add a new PHL § 3371(3) to provide that if it
appears that a crime related to the diversion of controlled substances
has been committed, DOH may notify the appropriate law enforcement agen-
cy and provide such information about the suspected criminal activity as
reasonably appears to be necessary.
Section 6 of Part of A of the bill would add new PHL § 3302(41) to
define the Registry.
Section 7 of Part A of the bill provides that Part A would take effect
one year after enactment, except that the Commissioner of Health and the
Commissioner of Education would be authorized to promulgate rules and
regulations and take other action necessary to implement Part A on its
effective date.
Part B. Electronic Prescribing
Section 1 of Part B of the bill would revise PHL Article 2-A to create a
new Title I, which would incorporate existing PHL §§ 270 through 276 and
section 277.
Section 1-a of Part B of the bill would renumber PHL §§ 276-a and 276-b
as §§ 278 and 279 respectively, and designate such sections and § 280 as
a new Title II.
Section 2 of Part B of the bill would amend PHL Article 2-A to add a new
Title III, consisting of new PHL § 281.
New PHL § 281 would incorporate the provisions of existing PHL § 21 into
subdivisions (1) and (2) and include a subdivision (3) requiring the
Commissioner of Health to promulgate regulations on or before December
31, 2012, establishing standards for electronic prescriptions for
controlled substances that are feasible and lawful under federal law.
New PHL § 281(3) would further provide that all prescriptions made in
this State on or after two years from that determination must be made by
electronic transmission from practitioners to pharmacists, with certain
specified exceptions.
Section 3 of Part B of the bill would amend Education Law § 6810 to
similarly require electronic prescribing for non-controlled substances.
Section 4 of Part B of the bill would repeal PHL § 21.
Section 5 of Part B of the bill provides that Part B would take effect
immediately.
Part C. Controlled Substance Schedules
Section 1 of Part C of the bill would amend Schedule II(b)(1) of PHL §
3306 to specify that hydrocodone, already listed, may also be known as
dihydrocodeinone, and to update the classification of oripavine.
Section 2 of Part C of the bill would add new Schedule II(b)(1) to PHL §
3306 to add to Schedule II those formulations of hydrocodone that
currently appear on Schedule III.
Section 3 of Part C of the bill would add new PHL § 3307(5) to require
the Commissioner of Health to establish minimum standards for the stor-
age, reporting, ordering and record keeping of the hydrocodone formu-
lations added to new Schedule II(b)(1) as if they were set forth in
Schedule III.
Section 4 of Part C of the bill would repeal Schedule II(b)(6), which
lists oripavine.
Section 5 of Part C of the bill would add a new Schedule II(c)(28) to
list tapentadol, which is an opiate, as a Schedule II substance.
Section 6 of the Part C of the bill would amend the opening paragraph of
Schedule II(d) to clarify that the inclusion of salts and isomers
applies whenever such salts or isomers are possible within the specific
chemical designation of a substance.
Section 7 of Part C of the bill would add a new Schedule II(g)(3) to
provide the chemical designation of a precursor to fentanyl.
Section 8 of Part C of the bill would amend Schedule II(h), pertaining
to anabolic steroids, to eliminate language describing the purposes of
such substances. The section would also add boldione, desoxymethyltes-
tosterone, and 19-nor-4,9(10)-androstadienedione to Schedule II and
correct typographical errors in the chemical designation of some of the
other listed substances.
Section 9 of Part C of the bill would amend the opening paragraph of
Schedule II1(c), to clarify that the inclusion of salts and isomers
applies whenever such salts or isomers are possible within the specific
chemical designation of a substance.
Section 10 of Part C of the bill would amend Schedule III(e) to remove
references to hydrocodone (dihydrocodeinone).
Section 11 of Part C of the bill would amend Schedule III(f) to clarify
the description of dronabinol.
Section 12 of Part C of the bill would amend Schedule IV(c) to add
fospropofol and carisoprodol to Schedule IV.
Section 13 of Part C of the bill would amend Schedule IV(e)(11) correct
a typographical error.
Section 14 of Part C of the bill would add new Schedule IV(f)(3) to
tramadol to Schedule IV.
Section 15 of Part C of the bill would amend Schedule V(b) correct a
typographical error.
Section 16 of Part C of the bill would amend Schedule V(d) to add two
additional substances, ezogabine and lacosamide, which are depressants,
to Schedule V.
Section 17 of Part C of the bill would make a technical change to PHL §
3331(7), correcting a reference to a drug that had been moved from one
place on the controlled substances schedules to another.
Section 18 of Part C of the bill would amend Penal Law § 220.00(8) to
classify hydrocodone, as added to Schedule II(b-1), as a "narcotic prep-
aration."
Section 21 of Part C of the bill provides that Part C would take effect
90 days after enactment, except that sections 2, 3, 10, 14 and 18 would
take effect 180 days after enactment and sections 15 and 17 would take
effect immediately.
Part D. Prescription Pain Medication Awareness Program
Sections 1 and 2 of Part D of the bill would amend PHL § 3309-a, which
requires DOH to establish a workgroup to make recommendations in the
implementation of the Prescription Pain Medication Awareness Program
enacted in the 2012-13 budget, to expand its functions. Under the bill,
the workgroup will be responsible for making recommendations on: (1)
continuing education for practitioners and pharmacists on pain manage-
ment issues; (2) protection and promotion of access of patients with a
legitimate need for controlled substances; (3) the implementation of the
Prescription Monitoring. Program provisions; and (4) the inclusion of
certain Schedule V substances in the consultation requirements of the
Prescription Monitoring Program.
Section 2 also would require the Commissioner of Health to include addi-
tional stakeholders on the workgroup, including but not limited to
consumer advocacy organizations, health care practitioners and provid-
ers, pharmacists and pharmacies, and law enforcement agencies.
Section 3 of Part D of the bill provides that Part D would take effect
immediately.
Part E. Safe Disposal
Section 1 of Part E of the bill would require DOH to establish a program
for the safe disposal of unused controlled substances by consumers.
Section 2 of Part E of the bill provides that Part E would take effect
immediately.
LEGISLATIVE HISTORY:
This is a new bill, although certain of its components have been
included in various legislative proposals.
STATEMENT IN SUPPORT:
Illicit use of prescription medicine has become the nation's "fastest-
growing drug problem," according to R. Gil Kerlikowske, Director of the
White House Office of National Drug Control Policy. According to the
federal Centers for Disease Control and Prevention (CDC), nearly 15,000
people die every year of overdoses due to prescription painkillers. In
2010, 1 in 20 people in the United States over the age of 11 reported
using prescription painkillers for nonmedical reasons in the past year.
During the period 1999 through 2008, overdose death rates, sales, and
substance abuse treatment admissions related to prescription painkillers
all increased substantially. Sales of opioid painkillers quadrupled
between 1999 and 2010. Enough opioid painkillers were prescribed in 2010
to medicate every American adult with 5 mg of hydrocodone every four
hours for a month. Moreover, an estimated 70 percent of people who abuse
prescription painkillers obtained them from friends or relatives who
originally received the medication from a prescription. The problem is
of particular concern with respect to young adults and teens.
Criminal diversion and abuse of prescription drugs results in addiction,
adverse drug events, accidental death due to overdose, violent or self-
injurious behavior, family conflicts, and increased costs to businesses
and the health care system. As a result, many individuals who suffer
from prescription drug abuse - as well as their families - have paid
heavy costs from this epidemic. This bill, together with other initi-
atives that will be implemented by DOH, sets forth a new strategy to
address the growth of prescription drug abuse in New York. This approach
seeks to minimize opportunities for addiction, abuse and criminal diver-
sion while protecting the ability of patients to access needed medica-
tions on a timely basis.
Part A. Creating a Modernized and Improved Prescription Monitoring
Program (I-STOP)
This legislation will require updating and modernization of DOH's
Prescription Monitoring Program (PMP) Registry - making it one of the
best systems in the nation to monitor prescription drug abuse and to
help the medical community provide better care. The PMP Registry will be
secure and easily accessible by practitioners and pharmacists, allowing
them to view their patients' controlled substance histories.
The new system will substantially decrease opportunities for "doctor
shoppers" to illegally obtain prescriptions from multiple practitioners.
The legislation will include information about dispensed controlled
substances reported by pharmacies on a "real time" basis-as determined
through a regulatory process, to effectively stop doctor shopping and
combat the circulation of illegally-obtained prescription drugs. The
"real time" approach in this legislation was modeled on the system
recently implemented in Oklahoma. Currently in New York, pharmacists are
required to report each controlled substance they dispense by no later
than the 15th day of the next month following the month in which the
substance was dispensed, which essentially means between 15 and 45 days
after dispensing.
In addition, practitioners will be required to consult the PMP before
prescribing or dispensing controlled substances listed on Schedule II,
III or IV of PHL § 3306 for the purpose of reviewing a patient's
controlled substance prescription history to help the practitioner
assess whether such prescription is necessary. Although this legislation
requires health care practitioners to consult the PMP Registry before
prescribing or dispensing the controlled substances that are most prone
to abuse and diversion, it strikes the right balance by exempting prac-
titioners from consulting in specific situations in order to protect
patient access to needed medications.
To help minimize administrative burdens on practitioners, the bill will
permit a practitioner to designate another person employed by or under
contract with the practitioner's practice to access the information on
behalf of the practitioner.
Moreover, pharmacists, for the first time, will now be able to consult
the PMP Registry before dispensing a controlled substance. Currently,
pharmacists do not have access to the PMP, meaning that they cannot
check to seek if a person who presents a prescription has a history that
suggests abuse or diversion of controlled substances. Many times a
patient who is attempting to obtain drugs for illegitimate purposes
presents a prescription where the prescribing practitioner is not from
the local area; the patient is unfamiliar to the pharmacist or is from
out of town; or the patient is picking up a prescription for someone
else. Access to a patient's recent controlled substance history that is
otherwise not available would provide additional information to pharma-
cists that may have concerns of the legitimacy of a prescription or
potential diversion.
Part B. Requiring Electronic Prescribing
New York will become a national leader by being one of the first states
to move from paper prescriptions to a system mandating the electronic
prescribing (e-prescribing) for all controlled substances. E-prescribing
is critical to help eliminate diversion that results from the alter-
ation, forgery, or theft of prescription paper.
Under this bill, e-prescribing would be mandatory for essentially all
prescriptions within approximately three years, with limited exceptions.
E-prescribing is a secure method of transmitting prescriptions from
practitioners to pharmacists. Since an c-prescription cannot be phys-
ically altered, forged, or stolen by individuals attempting to divert
controlled substances for addiction and illegal sale, it curtails
prescription fraud.
In addition, electronic prescribing enhances patient care by minimizing
medication errors due to misinterpretations of handwriting on written
prescriptions. It is estimated that 20 percent of the approximately
7,000 annual deaths caused by medication errors are attributable to
misinterpretations of written prescriptions. Moreover, medication errors
are estimated to cost the nation's health care system over $70 billion
each year. In New York, adverse drug events due to errors in written and
oral prescriptions carry an annual cost to the health care system of
approximately $130 million.
E-prescribing should also improve the efficiency of practitioners and
pharmacies; it has been estimated that approximately 30 percent of
prescriptions require pharmacists to call physicians due to poor hand-
writing on prescription forms. Additionally, e-prescribing is also more
convenient for consumers, who would otherwise need to either wait at the
pharmacy for a prescription to be filled or make separate trips to drop
off the prescription form and then pick up the medication.
Part C. Updating Controlled Substance Schedules
There are five controlled substance schedules. Schedule I controlled
substances may not be prescribed, dispensed, possessed, distributed or
administered except for research purposes with the approval of DOH.
Substances listed on Schedules II, III, IV and V may be prescribed only
by authorized practitioners. Schedule II controlled substances have a
high potential for abuse and addiction and are more difficult to divert
since a prescriber must issue a new prescription for each dispensing. By
regulation, Schedule II substances can be prescribed or dispensed in
supplies that do not exceed 30 days. However, to protect access to those
patients who need it the most, practitioners can prescribe a supply of
up to 90 days if he or she indicates, on the face of the prescription,
that the patient has one of several enumerated conditions, including
chronic pain.
Entries on the State schedules are not identical to those on the five
federal schedules of controlled substances (21 U.S.C. § 801). Drug-
seeking individuals often exploit the fact that certain drugs classified
as controlled substances under federal law are not controlled substances
under New York law and are more easily diverted. It is therefore impor-
tant, whenever appropriate, to add substances scheduled under federal
law to the State schedules. At the same time, the State should not wait
for federal action when it appears that a substance is dangerous and
should be scheduled. This bill would add several additional substances,
including some which have yet to be federally scheduled but warrant
inclusion in the State drug schedule, and move others from one schedule
to another, as specified below.
First, the bill would remove hydrocodone from Schedule III, where it is
listed for small quantities, meaning that hydrocodone would appear only
on Schedule II. Hydrocodone is among the most abused and diverted
prescription medications. Nationally, according to the 2010 Monitoring
the Future report by the University of Michigan, eight percent of all
high school seniors used hydrocodone for non-medical purpose. In 2009
alone, there were over 86,000 emergency room visits resulting from the
non-medical use of hydrocodone.
Second, the bill would add tramadol, a painkiller that has been shown to
be prone to abuse. Accordingly, the bill would add tramadol as a Sched-
ule IV substance.
Third, the bill would add carisoprodol to the schedules. Carisoprodol is
a skeletal muscle relaxant that acts directly on the central nervous
system and whose action in the body is similar to meprobamate, a Sched-
ule IV controlled substance. Excessive use of meprobamate can result in
psychological and physical dependence. Carisoprodol, when abused, is
typically combined with other controlled substances or alcohol. Abusers
who combine carisoprodol with hydrocodone claim that this combination
produces effects similar to those of heroin. On January 11, 2012, the
DEA placed carisoprodol in Schedule IV of the federal Controlled
Substance Act. In New York, the 2009 New York State Police Toxicology
Drug Statistics indicated that almost 200 of the 2,269 cases of driving
while ability-impaired (DWAI) related to drug use in that year were due
to carisoprodol use - an incidence that was higher than other controlled
substances such as stimulants, methadone and zolpidem. This bill would
add the substance to Schedule IV.
Fourth, the bill would add fospropofol to the State's controlled
substance Schedule IV. Fospropofol is currently used in sedation of
adult patients undergoing monitored anesthesia care sedation for diag-
nostic or therapeutic procedures. On November 11, 2009, fospropofol was
added by the DEA to Schedule IV of the federal Controlled Substance Act.
The DEA cited abuse among medical professionals as well as the potential
use of fospropofol as a "date-rape" drug in support of the decision to
schedule fospropofol.
Fifth, the bill would appropriately schedule oripavine, in conformance
with current DEA scheduling, under the category of opium and opiates and
any salt, compound, derivative or preparation of opium or opiates. The
DEA placed oripavine in Schedule II of the federal Controlled Substance
Schedule in 2007. Oripavine is a derivative of thebaine, a natural
constituent of opium.
Part D. Enhancing the Prescription Pain Medication Awareness Program
According to the CDC, a significant proportion - 17.3 percent - of
abused medications are prescribed to the person that abuses them. This
indicates a need for increased efforts to educate prescribers about the
dangers of overprescribing controlled substances, particularly opioids.
This bill therefore would enhance the Prescription Pain Medication
Awareness Program established by PHL § 3309-a, which requires DOH to
establish a workgroup to educate the public and health care practition-
ers about the risks associated with prescribing and taking controlled
substance pain medications The workgroup will be expanded to include
additional stakeholders on the workgroup, including but not limited to
consumer advocacy organizations, health care practitioners and provid-
ers, pharmacists and pharmacies, and law enforcement agencies. More-
over, under the bill, the workgroup would be charged with making recom-
mendations related to continuing education for practitioners and
pharmacists and to provide guidance in the implementation of the
Prescription Monitoring Program.
Part E. Establishing a Safe Disposal Program
An estimated 70 percent of people who abuse prescription painkillers
obtained them from friends or relatives, Therefore, it is critical to
provide consumers with a means of safely disposing of prescriptions.
Part D of this bill would require DOH to institute a program for the
safe disposal of unused controlled substances by consumers. DOH would
work with local police departments to establish secure disposal sites
for controlled substances on the premises of police stations. At these
sites, individuals would be able to voluntarily surrender unwanted and
unused controlled substances.
Under present law, individuals can only safely dispose of controlled
substances during an approved "take back" event. Various methods of
self-disposal are either burdensome or harmful to the environment.
Moreover, current federal regulations prohibit patients from returning
unused controlled substances to pharmacists and doctors. This program
would help alleviate this problem by providing a continual safe disposal
option to New Yorkers.
BUDGET IMPLICATIONS::
The bill is not expected to have a fiscal impact, as initial investments
can be covered within existing budgeted resources. In future years,
funds needed to support a contract to enhance and ultimately replace the
existing Registry will be substantially if not totally offset by a
decrease in costs associated with the State's obligation to provide
official forge-proof paper prescription forms to prescribers,
EFFECTIVE DATE::
The bill would take effect upon enactment, except that Part A would take
effect one year after enactment, although necessary regulations could be
promulgated before such time. In addition, Part C would take effect 90
days after enactment, except that sections 2, 3, 10, 14 and 18 would
take effect 180 days after enactment and sections 15 and 17 would take
effect immediately.
