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).
Sponsor: LANZA
Law Section: Public Health Law
Law: Rpld S21, S3306 schedule II sub (b) S6, amd Pub Health L, generally; amd S6810, Ed L; amd S220.00, Pen L
Co-sponsor(s):
HANNON, GOLDEN, SALAND, ALESI, AVELLA, BALL, BONACIC, CARLUCCI, DEFRANCISCO, FARLEY, FLANAGAN, FUSCHILLO, GALLIVAN, GRIFFO, GRISANTI, HASSELL-THOMPSON, JOHNSON, KENNEDY, KLEIN, LARKIN, LAVALLE, LIBOUS, LITTLE, MARCELLINO, MARTINS, MAZIARZ, MCDONALD, MONTGOMERY, NOZZOLIO, O'MARA, PERALTA, RANZENHOFER, RITCHIE, ROBACH, SAVINO, SEWARD, SKELOS, STOROBIN, VALESKY, YOUNG, ZELDIN
Law Section: Public Health Law
Law: Rpld S21, S3306 schedule II sub (b) S6, amd Pub Health L, generally; amd S6810, Ed L; amd S220.00, Pen L
S7637-2011 Actions
- Aug 27, 2012: SIGNED CHAP.447
- Aug 27, 2012: DELIVERED TO GOVERNOR
- Jun 11, 2012: returned to senate
- Jun 11, 2012: passed assembly
- Jun 11, 2012: ordered to third reading rules cal.142
- Jun 11, 2012: substituted for a10623
- Jun 11, 2012: referred to ways and means
- Jun 11, 2012: DELIVERED TO ASSEMBLY
- Jun 11, 2012: PASSED SENATE
- Jun 11, 2012: ORDERED TO THIRD READING CAL.1142
- Jun 11, 2012: REPORTED AND COMMITTED TO RULES
- Jun 8, 2012: REFERRED TO HEALTH
S7637-2011 Meetings
Health: Jun 11, 2012, Rules: Jun 18, 2012S7637-2011 Calendars
Floor Calendar: Jun 11, 2012S7637-2011 Votes
VOTE: COMMITTEE VOTE:
- Rules
- Jun 11, 2012
Ayes (22): Skelos, Alesi, Farley, Fuschillo, Hannon, Johnson, Larkin, LaValle, Libous, Marcellino, Maziarz, Nozzolio, Saland, Seward, Sampson, Breslin, Dilan, Hassell-Thompson, Parker, Perkins, Smith, Stewart-Cousins
Ayes W/R (2): Duane, Montgomery
Excused (1): Krueger
VOTE: FLOOR VOTE:
- Jun 11, 2012
Ayes (59): Adams, Addabbo, Alesi, Avella, Ball, Bonacic, Breslin, Carlucci, DeFrancisco, Diaz, Dilan, Duane, Farley, Flanagan, Fuschillo, Gallivan, Gianaris, Golden, Griffo, Grisanti, Hannon, Hassell-Thomps, Johnson, Kennedy, Klein, Lanza, Larkin, LaValle, Libous, Little, Marcellino, Martins, Maziarz, McDonald, Montgomery, Nozzolio, O'Mara, Oppenheimer, Parker, Peralta, Perkins, Ranzenhofer, Ritchie, Rivera, Robach, Saland, Sampson, Savino, Serrano, Seward, Skelos, Smith, Squadron, Stavisky, Stewart-Cousin, Storobin, Valesky, Young, Zeldin
Excused (3): Espaillat, Huntley, Krueger
S7637-2011 Memo
BILL NUMBER:S7637 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 Health 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 PHL � 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 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 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)to correct a typographical error. Section 14 of Part C of the bill would add tramadol to Schedule IV. Section 15 of Part C of the bill would amend Schedule V(b) to 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 in 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 see 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-prescrib- ing 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 e-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. Moreover, under the bill, the workgroup would be charged with making recommenda- tions related to continuing education for practitioners and pharmacists and to provide guidance in the implementation of the Prescription Moni- toring 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.
S7637-2011 Text
S T A T E O F N E W Y O R K
________________________________________________________________________
7637
I N SENATE
June 8, 2012
___________
Introduced by Sens. LANZA, HANNON, GOLDEN, SALAND -- (at request of the
Governor) -- (at request of the Attorney General) -- read twice and
ordered printed, and when printed to be committed to the Committee on
Health
AN ACT to amend the public health law, in relation to enacting the
internet system for tracking over-prescribing (I-STOP) act and creat-
ing 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 sche-
dules 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)
THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
BLY, DO ENACT AS FOLLOWS:
Section 1. Legislative findings and intent. The legislature finds
that prescription drugs, particularly controlled substances, are
increasingly subject to criminal diversion and abuse, which can result
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.
The legislature further finds that such diversion and abuse will be
mitigated by: establishing a prescription monitoring program registry
containing data about controlled substances dispensed to individuals,
reported on a real time basis; requiring health care practitioners and
permitting pharmacists to access such registry before prescribing or
dispensing additional such substances; and requiring that prescriptions
be transmitted electronically from practitioners to pharmacists. There-
fore, the legislature finds it appropriate and necessary to establish a
EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
[ ] is old law to be omitted.
S LBD12123-11-2
S. 7637 2
prescription monitoring program registry that is designed to utilize
real time data, integrate electronic prescribing, combat overprescribing
and doctor-shopping, and curtail abuse and illegal diversion without
compromising access to controlled substances for legitimate health care
purposes. The legislature further finds that these objectives will be
promoted by updating the state's schedules of controlled substances,
establishing a program for the safe disposal of controlled substances by
consumers, and enhancing opportunities to promote education about
controlled substances for the public and practitioners.
S 2. This act enacts into law major components of legislation which
are necessary to implement fundamental changes to the way controlled
substances are prescribed, dispensed and monitored in this state. Each
component is wholly contained within a Part identified as Parts A
through E. The effective date of each particular provision contained
within such Part is set forth in the last section of such Part. Any
provision in any section contained within a Part, including the effec-
tive date of the Part, which makes reference to a section "of this act",
when used in connection with that particular component, shall be deemed
to mean and refer to the corresponding section of the Part in which it
is found. Section four of this act sets forth the general effective date
of this act.
PART A
Section 1. This act shall be known and may be cited as the "Internet
System for Tracking Over-Prescribing (I-STOP) Act".
S 2. The public health law is amended by adding a new section 3343-a
to read as follows:
S 3343-A. PRESCRIPTION MONITORING PROGRAM REGISTRY. 1. ESTABLISHMENT
OF SYSTEM. (A) THE COMMISSIONER SHALL, IN ACCORDANCE WITH THE PROVISIONS
OF THIS SECTION, ESTABLISH AND MAINTAIN AN ELECTRONIC SYSTEM FOR
COLLECTING, MONITORING AND REPORTING INFORMATION CONCERNING THE
PRESCRIBING AND DISPENSING OF CONTROLLED SUBSTANCES, TO BE KNOWN AS THE
PRESCRIPTION MONITORING PROGRAM REGISTRY. THE REGISTRY SHALL INCLUDE
INFORMATION REPORTED BY PHARMACIES ON A REAL TIME BASIS, AS SET FORTH IN
SUBDIVISION FOUR OF SECTION THIRTY-THREE HUNDRED THIRTY-THREE OF THIS
ARTICLE.
(B) THE REGISTRY SHALL INCLUDE, FOR EACH PERSON TO WHOM A PRESCRIPTION
FOR CONTROLLED SUBSTANCES HAS BEEN DISPENSED, ALL PATIENT-SPECIFIC
INFORMATION COVERING SUCH PERIOD OF TIME AS IS DEEMED APPROPRIATE AND
FEASIBLE BY THE COMMISSIONER, BUT NO LESS THAN SIX MONTHS AND NO MORE
THAN FIVE YEARS. SUCH PATIENT-SPECIFIC INFORMATION SHALL BE OBTAINED
FROM THE PRESCRIPTION INFORMATION REPORTED BY PHARMACIES PURSUANT TO
SUBDIVISION FOUR OF SECTION THIRTY-THREE HUNDRED THIRTY-THREE OF THIS
ARTICLE AND BY PRACTITIONERS WHO DISPENSE PURSUANT TO SUBDIVISION SIX OF
SECTION THIRTY-THREE HUNDRED THIRTY-ONE OF THIS ARTICLE, AND SHALL BE
PROCESSED AND INCLUDED IN THE REGISTRY BY THE DEPARTMENT WITHOUT UNDUE
DELAY. FOR PURPOSES OF THIS ARTICLE, "PATIENT-SPECIFIC INFORMATION"
MEANS INFORMATION PERTAINING TO INDIVIDUAL PATIENTS INCLUDED IN THE
REGISTRY, WHICH SHALL INCLUDE THE FOLLOWING INFORMATION AND SUCH OTHER
INFORMATION AS IS REQUIRED BY THE DEPARTMENT IN REGULATION:
(I) THE PATIENT'S NAME;
(II) THE PATIENT'S RESIDENTIAL ADDRESS;
(III) THE PATIENT'S DATE OF BIRTH;
(IV) THE PATIENT'S GENDER;
(V) THE DATE ON WHICH THE PRESCRIPTION WAS ISSUED;
S. 7637 3
(VI) THE DATE ON WHICH THE CONTROLLED SUBSTANCE WAS DISPENSED;
(VII) THE METRIC QUANTITY OF THE CONTROLLED SUBSTANCE DISPENSED;
(VIII) THE NUMBER OF DAYS SUPPLY OF THE CONTROLLED SUBSTANCE
DISPENSED;
(IX) THE NAME OF THE PRESCRIBER;
(X) THE PRESCRIBER'S IDENTIFICATION NUMBER, AS ASSIGNED BY THE DRUG
ENFORCEMENT ADMINISTRATION;
(XI) THE NAME OR IDENTIFIER OF THE DRUG THAT WAS DISPENSED; AND
(XII) THE PAYMENT METHOD.
(C) THE REGISTRY SHALL BE SECURE, EASILY ACCESSIBLE BY PRACTITIONERS
AND PHARMACISTS, AND COMPATIBLE WITH THE ELECTRONIC TRANSMISSION OF
PRESCRIPTIONS FOR CONTROLLED SUBSTANCES, AS REQUIRED BY SECTION TWO
HUNDRED EIGHTY-ONE OF THIS CHAPTER, AND SECTION SIXTY-EIGHT HUNDRED TEN
OF THE EDUCATION LAW, AND ANY REGULATIONS PROMULGATED PURSUANT THERETO.
TO THE EXTENT PRACTICABLE, IMPLEMENTATION OF THE ELECTRONIC TRANSMISSION
OF PRESCRIPTIONS FOR CONTROLLED SUBSTANCES SHALL SERVE TO STREAMLINE
CONSULTATION OF THE REGISTRY BY PRACTITIONERS AND REPORTING OF
PRESCRIPTION INFORMATION BY PHARMACISTS. THE REGISTRY SHALL BE INTEROP-
ERABLE WITH OTHER SIMILAR REGISTRIES OPERATED BY FEDERAL OR STATE
GOVERNMENTS, TO THE EXTENT DEEMED APPROPRIATE BY THE COMMISSIONER, AND
SUBJECT TO THE PROVISIONS OF SECTION THIRTY-THREE HUNDRED SEVENTY-ONE-A
OF THIS ARTICLE.
(D) THE DEPARTMENT SHALL ESTABLISH AND IMPLEMENT SUCH PROTOCOLS AS ARE
REASONABLY NECESSARY TO ENSURE THAT INFORMATION CONTAINED IN THE REGIS-
TRY IS MAINTAINED IN A SECURE AND CONFIDENTIAL MANNER AND IS ACCESSIBLE
ONLY BY PRACTITIONERS, PHARMACISTS OR THEIR DESIGNEES FOR THE PURPOSES
ESTABLISHED IN SUBDIVISIONS TWO AND THREE OF THIS SECTION, OR AS OTHER-
WISE SET FORTH IN SECTIONS THIRTY-THREE HUNDRED SEVENTY-ONE AND THIRTY-
THREE HUNDRED SEVENTY-ONE-A OF THIS ARTICLE. SUCH PROTOCOLS SHALL
INCLUDE A MECHANISM FOR THE DEPARTMENT TO MONITOR AND RECORD ACCESS TO
THE REGISTRY, WHICH SHALL IDENTIFY THE AUTHORIZED INDIVIDUAL ACCESSING
AND EACH CONTROLLED SUBSTANCE HISTORY ACCESSED.
2. DUTY TO CONSULT PRESCRIPTION MONITORING PROGRAM REGISTRY; PRACTI-
TIONERS. (A) EVERY PRACTITIONER SHALL CONSULT THE PRESCRIPTION MONITOR-
ING PROGRAM REGISTRY PRIOR TO PRESCRIBING OR DISPENSING ANY CONTROLLED
SUBSTANCE LISTED ON SCHEDULE II, III OR IV OF SECTION THIRTY-THREE
HUNDRED SIX OF THIS ARTICLE, FOR THE PURPOSE OF REVIEWING A PATIENT'S
CONTROLLED SUBSTANCE HISTORY AS SET FORTH IN SUCH REGISTRY; PROVIDED,
HOWEVER, THAT NOTHING IN THIS SECTION SHALL PRECLUDE AN AUTHORIZED PRAC-
TITIONER, OTHER THAN A VETERINARIAN, FROM CONSULTING THE REGISTRY AT HIS
OR HER OPTION PRIOR TO PRESCRIBING OR DISPENSING ANY CONTROLLED
SUBSTANCE. THE DUTY TO CONSULT THE REGISTRY SHALL NOT APPLY TO:
(I) VETERINARIANS;
(II) A PRACTITIONER DISPENSING PURSUANT TO SUBDIVISION THREE OF
SECTION THIRTY-THREE HUNDRED FIFTY-ONE OF THIS ARTICLE;
(III) A PRACTITIONER ADMINISTERING A CONTROLLED SUBSTANCE;
(IV) A PRACTITIONER PRESCRIBING OR ORDERING A CONTROLLED SUBSTANCE FOR
USE ON THE PREMISES OF AN INSTITUTIONAL DISPENSER PURSUANT TO SECTION
THIRTY-THREE HUNDRED FORTY-TWO OF THIS TITLE;
(V) A PRACTITIONER PRESCRIBING A CONTROLLED SUBSTANCE IN THE EMERGENCY
DEPARTMENT OF A GENERAL HOSPITAL, PROVIDED THAT THE QUANTITY OF
CONTROLLED SUBSTANCE PRESCRIBED DOES NOT EXCEED A FIVE DAY SUPPLY IF THE
CONTROLLED SUBSTANCE WERE USED IN ACCORDANCE WITH THE DIRECTIONS FOR
USE;
S. 7637 4
(VI) A PRACTITIONER PRESCRIBING A CONTROLLED SUBSTANCE TO A PATIENT
UNDER THE CARE OF A HOSPICE, AS DEFINED BY SECTION FOUR THOUSAND TWO OF
THIS CHAPTER;
(VII) A PRACTITIONER WHEN:
(A) IT IS NOT REASONABLY POSSIBLE FOR THE PRACTITIONER TO ACCESS THE
REGISTRY IN A TIMELY MANNER;
(B) NO OTHER PRACTITIONER OR DESIGNEE AUTHORIZED TO ACCESS THE REGIS-
TRY, PURSUANT TO PARAGRAPH (B) OF THIS SUBDIVISION, IS REASONABLY AVAIL-
ABLE; AND
(C) THE QUANTITY OF CONTROLLED SUBSTANCE PRESCRIBED DOES NOT EXCEED A
FIVE DAY SUPPLY IF THE CONTROLLED SUBSTANCE WERE USED IN ACCORDANCE WITH
THE DIRECTIONS FOR USE;
(VIII) A PRACTITIONER ACTING IN COMPLIANCE WITH REGULATIONS THAT MAY
BE PROMULGATED BY THE COMMISSIONER AS TO CIRCUMSTANCES UNDER WHICH
CONSULTATION OF THE 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;
(IX) A SITUATION WHERE THE REGISTRY IS NOT OPERATIONAL AS DETERMINED
BY THE DEPARTMENT OR WHERE IT CANNOT BE ACCESSED BY THE PRACTITIONER DUE
TO A TEMPORARY TECHNOLOGICAL OR ELECTRICAL FAILURE, AS SET FORTH IN
REGULATION; OR
(X) A PRACTITIONER WHO HAS BEEN GRANTED A WAIVER DUE TO TECHNOLOGICAL
LIMITATIONS THAT ARE NOT REASONABLY WITHIN THE CONTROL OF THE PRACTI-
TIONER, OR OTHER EXCEPTIONAL CIRCUMSTANCE DEMONSTRATED BY THE PRACTI-
TIONER, PURSUANT TO A PROCESS ESTABLISHED IN REGULATION, AND IN THE
DISCRETION OF THE COMMISSIONER.
(B) FOR PURPOSES OF THIS SECTION, A PRACTITIONER MAY AUTHORIZE A
DESIGNEE TO CONSULT THE PRESCRIPTION MONITORING PROGRAM REGISTRY ON HIS
OR HER BEHALF, PROVIDED THAT: (I) THE DESIGNEE SO AUTHORIZED IS EMPLOYED
BY THE SAME PROFESSIONAL PRACTICE OR IS UNDER CONTRACT WITH SUCH PRAC-
TICE; (II) THE PRACTITIONER TAKES REASONABLE STEPS TO ENSURE THAT SUCH
DESIGNEE IS SUFFICIENTLY COMPETENT IN THE USE OF THE REGISTRY; (III) THE
PRACTITIONER REMAINS RESPONSIBLE FOR ENSURING THAT ACCESS TO THE REGIS-
TRY BY THE DESIGNEE IS LIMITED TO AUTHORIZED PURPOSES AND OCCURS IN A
MANNER THAT PROTECTS THE CONFIDENTIALITY OF THE INFORMATION OBTAINED
FROM THE REGISTRY, AND REMAINS RESPONSIBLE FOR ANY BREACH OF CONFIDEN-
TIALITY; AND (IV) THE ULTIMATE DECISION AS TO WHETHER OR NOT TO
PRESCRIBE OR DISPENSE A CONTROLLED SUBSTANCE REMAINS WITH THE PRACTI-
TIONER AND IS REASONABLY INFORMED BY THE RELEVANT CONTROLLED SUBSTANCE
HISTORY INFORMATION OBTAINED FROM THE REGISTRY. THE COMMISSIONER SHALL
ESTABLISH IN REGULATION REASONABLE PARAMETERS WITH REGARD TO A PRACTI-
TIONER'S ABILITY TO AUTHORIZE DESIGNEES PURSUANT TO THIS SECTION, WHICH
SHALL INCLUDE PROCESSES NECESSARY TO ALLOW THE DEPARTMENT TO: (A) GRANT
ACCESS TO THE REGISTRY IN A REASONABLY PROMPT MANNER TO AS MANY DESIG-
NEES AS ARE AUTHORIZED BY PRACTITIONERS, UP TO THE NUMBER DEEMED APPRO-
PRIATE BY THE COMMISSIONER FOR PARTICULAR PROFESSIONAL PRACTICES OR
TYPES OF PRACTICES, TAKING INTO ACCOUNT THE NEED TO MAINTAIN SECURITY OF
THE REGISTRY AND THE PATIENT-SPECIFIC INFORMATION MAINTAINED THEREIN,
AND THE OBJECTIVE OF MINIMIZING BURDENS TO PRACTITIONERS TO THE EXTENT
PRACTICABLE; (B) REQUIRE THAT PRACTITIONERS NOTIFY THE DEPARTMENT UPON
TERMINATING THE AUTHORIZATION OF ANY DESIGNEE; AND (C) ESTABLISH A MECH-
ANISM TO PREVENT SUCH TERMINATED DESIGNEES FROM ACCESSING THE REGISTRY
IN A REASONABLY PROMPT MANNER FOLLOWING SUCH NOTIFICATION.
3. AUTHORITY TO CONSULT PRESCRIPTION MONITORING PROGRAM REGISTRY;
PHARMACISTS. (A) A PHARMACIST MAY CONSULT THE PRESCRIPTION MONITORING
PROGRAM REGISTRY IN ORDER TO REVIEW THE CONTROLLED SUBSTANCE HISTORY OF
S. 7637 5
AN INDIVIDUAL FOR WHOM ONE OR MORE PRESCRIPTIONS FOR CONTROLLED
SUBSTANCES IS PRESENTED TO SUCH PHARMACIST.
(B) FOR PURPOSES OF THIS SECTION, A PHARMACIST MAY DESIGNATE ANOTHER
PHARMACIST, A PHARMACY INTERN, AS DEFINED BY SECTION SIXTY-EIGHT HUNDRED
SIX OF THE EDUCATION LAW, OR OTHER INDIVIDUAL AS MAY BE PERMITTED BY THE
COMMISSIONER IN REGULATION, TO CONSULT THE PRESCRIPTION MONITORING
PROGRAM REGISTRY ON THE PHARMACIST'S BEHALF, PROVIDED THAT SUCH DESIGNEE
IS EMPLOYED BY THE SAME PHARMACY OR IS UNDER CONTRACT WITH SUCH PHARMA-
CY. THE COMMISSIONER SHALL ESTABLISH IN REGULATION REASONABLE PARAME-
TERS WITH REGARD TO A PHARMACIST'S ABILITY TO AUTHORIZE DESIGNEES PURSU-
ANT TO THIS SECTION, WHICH SHALL INCLUDE PROCESSES NECESSARY TO ALLOW
THE DEPARTMENT TO: (A) GRANT ACCESS TO THE REGISTRY IN A REASONABLY
PROMPT MANNER TO AS MANY DESIGNEES AS ARE AUTHORIZED BY PHARMACISTS, UP
TO THE NUMBER DEEMED APPROPRIATE BY THE COMMISSIONER FOR PARTICULAR
PHARMACIES, TAKING INTO ACCOUNT THE NEED TO MAINTAIN SECURITY OF THE
REGISTRY AND THE PATIENT-SPECIFIC INFORMATION MAINTAINED THEREIN, AND
THE OBJECTIVE OF MINIMIZING BURDENS TO PHARMACISTS TO THE EXTENT PRACTI-
CABLE; (B) REQUIRE THAT PHARMACISTS NOTIFY THE DEPARTMENT UPON TERMINAT-
ING THE AUTHORIZATION OF ANY DESIGNEE; AND (C) ESTABLISH A MECHANISM TO
PREVENT SUCH TERMINATED DESIGNEES FROM ACCESSING THE REGISTRY IN A
REASONABLY PROMPT MANNER FOLLOWING SUCH NOTIFICATION.
4. IMMUNITY. NO PRACTITIONER OR PHARMACIST, AND NO PERSON ACTING ON
BEHALF OF SUCH PRACTITIONER OR PHARMACIST AS PERMITTED UNDER THIS
SECTION, ACTING WITH REASONABLE CARE AND IN GOOD FAITH SHALL BE SUBJECT
TO CIVIL LIABILITY ARISING FROM ANY FALSE, INCOMPLETE OR INACCURATE
INFORMATION SUBMITTED TO OR REPORTED BY THE REGISTRY OR FOR ANY RESULT-
ING FAILURE OF THE SYSTEM TO ACCURATELY OR TIMELY REPORT SUCH INFORMA-
TION; PROVIDED, HOWEVER, THAT NOTHING IN THIS SUBDIVISION SHALL BE
DEEMED TO ALTER THE OBLIGATION TO SUBMIT OR REPORT PRESCRIPTION INFORMA-
TION TO THE DEPARTMENT AS OTHERWISE SET FORTH IN THIS ARTICLE OR IN
REGULATIONS PROMULGATED PURSUANT THERETO.
5. GUIDANCE TO PRACTITIONERS AND PHARMACISTS. THE COMMISSIONER SHALL,
IN CONSULTATION WITH THE COMMISSIONER OF EDUCATION, PROVIDE GUIDANCE TO
PRACTITIONERS, PHARMACISTS, AND PHARMACIES REGARDING THE PURPOSES AND
USES OF THE REGISTRY ESTABLISHED BY THIS SECTION AND THE MEANS BY WHICH
PRACTITIONERS AND PHARMACISTS CAN ACCESS THE REGISTRY. SUCH GUIDANCE
SHALL REFERENCE EDUCATIONAL INFORMATION AVAILABLE PURSUANT TO THE
PRESCRIPTION PAIN MEDICATION AWARENESS PROGRAM ESTABLISHED PURSUANT TO
SECTION THIRTY-THREE HUNDRED NINE-A OF THIS ARTICLE.
6. INDIVIDUAL ACCESS TO CONTROLLED SUBSTANCE HISTORIES. THE COMMIS-
SIONER SHALL ESTABLISH PROCEDURES BY WHICH AN INDIVIDUAL MAY: (A)
REQUEST AND OBTAIN HIS OR HER OWN CONTROLLED SUBSTANCES HISTORY CONSIST-
ING OF PATIENT-SPECIFIC INFORMATION OR, IN APPROPRIATE CIRCUMSTANCES,
THAT OF A PATIENT WHO LACKS CAPACITY TO MAKE HEALTH CARE DECISIONS AND
FOR WHOM THE INDIVIDUAL HAS LEGAL AUTHORITY TO MAKE SUCH DECISIONS AND
WOULD HAVE LEGAL ACCESS TO THE PATIENT'S HEALTH CARE RECORDS; OR (B)
SEEK REVIEW OF ANY PART OF HIS OR HER CONTROLLED SUBSTANCES HISTORY OR,
IN APPROPRIATE CIRCUMSTANCES, THAT OF A PATIENT WHO LACKS CAPACITY TO
MAKE HEALTH CARE DECISIONS AND FOR WHOM THE INDIVIDUAL HAS LEGAL AUTHOR-
ITY TO MAKE SUCH DECISIONS AND WOULD HAVE LEGAL ACCESS TO THE PATIENT'S
HEALTH CARE RECORDS, THAT SUCH INDIVIDUAL DISPUTES. SUCH PROCEDURES
SHALL REQUIRE THE DEPARTMENT TO PROMPTLY REVISE ANY INFORMATION ACCESSI-
BLE THROUGH THE REGISTRY THAT THE DEPARTMENT DETERMINES TO BE INACCU-
RATE. SUCH PROCEDURES SHALL BE DESCRIBED ON THE DEPARTMENT'S WEBSITE AND
INCLUDED WITH THE CONTROLLED SUBSTANCES HISTORY PROVIDED TO AN INDIVID-
UAL PURSUANT TO A REQUEST MADE UNDER THIS SUBDIVISION OR UNDER SUBPARA-
S. 7637 6
GRAPH (IV) OF PARAGRAPH (A) OF SUBDIVISION TWO OF SECTION THIRTY-THREE
HUNDRED SEVENTY-ONE OF THIS ARTICLE.
7. DEPARTMENT ANALYSIS OF DATA. THE DEPARTMENT SHALL PERIODICALLY
ANALYZE DATA CONTAINED IN THE PRESCRIPTION MONITORING PROGRAM REGISTRY
TO IDENTIFY INFORMATION THAT INDICATES THAT A VIOLATION OF LAW OR BREACH
OF PROFESSIONAL STANDARDS MAY HAVE OCCURRED AND, AS WARRANTED, PROVIDE
ANY RELEVANT INFORMATION TO APPROPRIATE ENTITIES AS PERMITTED UNDER
SECTION THIRTY-THREE HUNDRED SEVENTY-ONE OF THIS ARTICLE. THE DEPART-
MENT SHALL KEEP A RECORD OF THE INFORMATION PROVIDED, INCLUDING, BUT NOT
LIMITED TO, THE SPECIFIC INFORMATION PROVIDED AND THE AGENCY TO WHICH
SUCH INFORMATION WAS PROVIDED, INCLUDING THE NAME AND TITLE OF THE
PERSON TO WHOM SUCH INFORMATION WAS PROVIDED AND AN ATTESTATION FROM
SUCH PERSON THAT HE OR SHE HAS AUTHORITY TO RECEIVE SUCH INFORMATION.
8. FUNDING THE PRESCRIPTION MONITORING PROGRAM REGISTRY. (A) THE
COMMISSIONER SHALL MAKE REASONABLE EFFORTS TO APPLY FOR MONIES AVAILABLE
FROM THE FEDERAL GOVERNMENT AND OTHER INSTITUTIONS, TO THE EXTENT DEEMED
APPROPRIATE BY THE COMMISSIONER, AND USE ANY MONIES SO OBTAINED TO
SUPPLEMENT ANY OTHER MONIES MADE AVAILABLE FOR THE PURPOSES OF THIS
TITLE.
(B) OPERATION OF THE REGISTRY ESTABLISHED BY THIS SECTION SHALL NOT BE
FUNDED, IN WHOLE OR IN PART, BY FEES IMPOSED SPECIFICALLY FOR SUCH
PURPOSES UPON PRACTITIONERS, PHARMACISTS, DESIGNEES OR PATIENTS SUBJECT
TO THIS SECTION.
9. RULES AND REGULATIONS. THE COMMISSIONER SHALL PROMULGATE SUCH RULES
AND REGULATIONS AS ARE NECESSARY TO EFFECTUATE THE PROVISIONS OF THIS
SECTION, IN CONSULTATION WITH THE WORK GROUP ESTABLISHED PURSUANT TO
SUBDIVISION THREE OF SECTION THIRTY-THREE HUNDRED NINE-A OF THIS ARTI-
CLE.
S 3. Subdivision 4 of section 3333 of the public health law, as
amended by chapter 178 of the laws of 2010, is amended to read as
follows:
4. The endorsed original prescription shall be retained by the propri-
etor of the pharmacy for a period of five years. The proprietor of the
pharmacy shall file OR CAUSE TO BE FILED such prescription information
with the department by electronic means [in such manner and detail] ON A
REAL TIME BASIS as the commissioner in consultation with the commission-
er of education shall, by regulation, require; PROVIDED, HOWEVER, THAT
THE COMMISSIONER MAY, PURSUANT TO A PROCESS ESTABLISHED IN REGULATION,
GRANT A WAIVER ALLOWING A PHARMACY TO MAKE SUCH FILINGS WITHIN A LONGER
PERIOD OF TIME IF AND TO THE EXTENT THAT THE COMMISSIONER FINDS IT
WARRANTED, IN HIS OR HER DISCRETION, DUE TO ECONOMIC HARDSHIP, TECHNO-
LOGICAL LIMITATIONS THAT ARE NOT REASONABLY WITHIN THE CONTROL OF THE
PHARMACY, OR OTHER EXCEPTIONAL CIRCUMSTANCE DEMONSTRATED BY THE
PHARMACY; AND PROVIDED, FURTHER, HOWEVER, THAT SUCH REGULATIONS SHALL
SPECIFY THE MANNER IN WHICH SUCH REQUIREMENTS SHALL APPLY TO THE DELIV-
ERY OF CONTROLLED SUBSTANCES TO INDIVIDUALS IN THIS STATE BY MEANS OF
MAIL OR LICENSED EXPRESS DELIVERY SERVICES.
S 4. Paragraphs (d) and (e) of subdivision 1 of section 3371 of the
public health law, as amended by chapter 178 of the laws of 2010, are
amended and five new paragraphs (f), (g), (h), (i) and (j) are added to
read as follows:
(d) to [a central] THE PRESCRIPTION MONITORING PROGRAM registry
[established pursuant to this article; and] AND TO AUTHORIZED USERS OF
SUCH REGISTRY AS SET FORTH IN SUBDIVISION TWO OF THIS SECTION;
(e) to a practitioner to inform him or her that a patient may be under
treatment with a controlled substance by another practitioner[.] FOR THE
S. 7637 7
PURPOSES OF SUBDIVISION TWO OF THIS SECTION, AND TO FACILITATE THE
DEPARTMENT'S REVIEW OF INDIVIDUAL CHALLENGES TO THE ACCURACY OF
CONTROLLED SUBSTANCES HISTORIES PURSUANT TO SUBDIVISION SIX OF SECTION
THIRTY-THREE HUNDRED FORTY-THREE-A OF THIS ARTICLE;
(F) TO A PHARMACIST TO PROVIDE INFORMATION REGARDING PRESCRIPTIONS FOR
CONTROLLED SUBSTANCES PRESENTED TO THE PHARMACIST FOR THE PURPOSES OF
SUBDIVISION TWO OF THIS SECTION AND TO FACILITATE THE DEPARTMENT'S
REVIEW OF INDIVIDUAL CHALLENGES TO THE ACCURACY OF CONTROLLED SUBSTANCES
HISTORIES PURSUANT TO SUBDIVISION SIX OF SECTION THIRTY-THREE HUNDRED
FORTY-THREE-A OF THIS ARTICLE;
(G) TO THE DEPUTY ATTORNEY GENERAL FOR MEDICAID FRAUD CONTROL, OR HIS
OR HER DESIGNEE, IN FURTHERANCE OF AN INVESTIGATION OF FRAUD, WASTE OR
ABUSE OF THE MEDICAID PROGRAM, PURSUANT TO AN AGREEMENT WITH THE DEPART-
MENT;
(H) TO A LOCAL HEALTH DEPARTMENT FOR THE PURPOSE OF CONDUCTING PUBLIC
HEALTH RESEARCH OR EDUCATION: (I) PURSUANT TO AN AGREEMENT WITH THE
COMMISSIONER; (II) WHEN THE RELEASE OF SUCH INFORMATION IS DEEMED APPRO-
PRIATE BY THE COMMISSIONER; (III) FOR USE IN ACCORDANCE WITH MEASURES
REQUIRED BY THE COMMISSIONER TO ENSURE THAT THE SECURITY AND CONFIDEN-
TIALITY OF THE DATA IS PROTECTED; AND (IV) PROVIDED THAT DISCLOSURE IS
RESTRICTED TO INDIVIDUALS WITHIN THE LOCAL HEALTH DEPARTMENT WHO ARE
ENGAGED IN THE RESEARCH OR EDUCATION;
(I) TO A MEDICAL EXAMINER OR CORONER WHO IS AN OFFICER OF OR EMPLOYED
BY A STATE OR LOCAL GOVERNMENT, PURSUANT TO HIS OR HER OFFICIAL DUTIES;
AND
(J) TO AN INDIVIDUAL FOR THE PURPOSE OF PROVIDING SUCH INDIVIDUAL WITH
HIS OR HER OWN CONTROLLED SUBSTANCE HISTORY OR, IN APPROPRIATE CIRCUM-
STANCES, IN THE CASE OF A PATIENT WHO LACKS CAPACITY TO MAKE HEALTH CARE
DECISIONS, A PERSON WHO HAS LEGAL AUTHORITY TO MAKE SUCH DECISIONS FOR
THE PATIENT AND WHO WOULD HAVE LEGAL ACCESS TO THE PATIENT'S HEALTH CARE
RECORDS, IF REQUESTED FROM THE DEPARTMENT PURSUANT TO SUBDIVISION SIX OF
SECTION THIRTY-THREE HUNDRED FORTY-THREE-A OF THIS ARTICLE OR FROM A
TREATING PRACTITIONER PURSUANT TO SUBPARAGRAPH (IV) OF PARAGRAPH (A) OF
SUBDIVISION TWO OF THIS SECTION.
S 5. Subdivision 2 of section 3371 of the public health law is renum-
bered subdivision 4 and two new subdivisions 2 and 3 are added to read
as follows:
2. THE PRESCRIPTION MONITORING PROGRAM REGISTRY MAY BE ACCESSED, UNDER
SUCH TERMS AND CONDITIONS AS ARE ESTABLISHED BY THE DEPARTMENT FOR
PURPOSES OF MAINTAINING THE SECURITY AND CONFIDENTIALITY OF THE INFORMA-
TION CONTAINED IN THE REGISTRY, BY:
(A) A PRACTITIONER, OR A DESIGNEE AUTHORIZED BY SUCH PRACTITIONER
PURSUANT TO PARAGRAPH (B) OF SUBDIVISION TWO OF SECTION THIRTY-THREE
HUNDRED FORTY-THREE-A OF THIS ARTICLE, FOR THE PURPOSES OF: (I) INFORM-
ING THE PRACTITIONER THAT A PATIENT MAY BE UNDER TREATMENT WITH A
CONTROLLED SUBSTANCE BY ANOTHER PRACTITIONER; (II) PROVIDING THE PRACTI-
TIONER WITH NOTIFICATIONS OF CONTROLLED SUBSTANCE ACTIVITY AS DEEMED
RELEVANT BY THE DEPARTMENT, INCLUDING BUT NOT LIMITED TO A NOTIFICATION
MADE AVAILABLE ON A MONTHLY OR OTHER PERIODIC BASIS THROUGH THE REGISTRY
OF CONTROLLED SUBSTANCES ACTIVITY PERTAINING TO HIS OR HER PATIENT;
(III) ALLOWING THE PRACTITIONER, THROUGH CONSULTATION OF THE
PRESCRIPTION MONITORING PROGRAM REGISTRY, TO REVIEW HIS OR HER PATIENT'S
CONTROLLED SUBSTANCES HISTORY AS REQUIRED BY SECTION THIRTY-THREE
HUNDRED FORTY-THREE-A OF THIS ARTICLE; AND (IV) PROVIDING TO HIS OR HER
PATIENT, OR PERSON AUTHORIZED PURSUANT TO PARAGRAPH (J) OF SUBDIVISION
ONE OF THIS SECTION, UPON REQUEST, A COPY OF SUCH PATIENT'S CONTROLLED
S. 7637 8
SUBSTANCE HISTORY AS IS AVAILABLE TO THE PRACTITIONER THROUGH THE
PRESCRIPTION MONITORING PROGRAM REGISTRY; OR
(B) A PHARMACIST, PHARMACY INTERN OR OTHER DESIGNEE AUTHORIZED BY THE
PHARMACIST PURSUANT TO PARAGRAPH (B) OF SUBDIVISION THREE OF SECTION
THIRTY-THREE HUNDRED FORTY-THREE-A OF THIS ARTICLE, FOR THE PURPOSES OF:
(I) CONSULTING THE PRESCRIPTION MONITORING PROGRAM REGISTRY TO REVIEW
THE CONTROLLED SUBSTANCES HISTORY OF AN INDIVIDUAL FOR WHOM ONE OR MORE
PRESCRIPTIONS FOR CONTROLLED SUBSTANCES IS PRESENTED TO THE PHARMACIST,
PURSUANT TO SECTION THIRTY-THREE HUNDRED FORTY-THREE-A OF THIS ARTICLE;
AND (II) RECEIVING FROM THE DEPARTMENT SUCH NOTIFICATIONS OF CONTROLLED
SUBSTANCE ACTIVITY AS ARE MADE AVAILABLE BY THE DEPARTMENT.
3. WHERE IT HAS REASON TO BELIEVE THAT A CRIME RELATED TO THE DIVER-
SION OF CONTROLLED SUBSTANCES HAS BEEN COMMITTED, THE DEPARTMENT MAY
NOTIFY APPROPRIATE LAW ENFORCEMENT AGENCIES AND PROVIDE RELEVANT INFOR-
MATION ABOUT THE SUSPECTED CRIMINAL ACTIVITY, INCLUDING CONTROLLED
SUBSTANCES PRESCRIBED OR DISPENSED, AS REASONABLY APPEARS TO BE NECES-
SARY. THE DEPARTMENT SHALL KEEP A RECORD OF THE INFORMATION PROVIDED,
INCLUDING, BUT NOT LIMITED TO: THE SPECIFIC INFORMATION PROVIDED AND THE
AGENCY TO WHICH SUCH INFORMATION WAS PROVIDED, INCLUDING THE NAME AND
TITLE OF THE PERSON TO WHOM SUCH INFORMATION WAS PROVIDED AND AN ATTES-
TATION FROM SUCH PERSON THAT HE OR SHE HAS AUTHORITY TO RECEIVE SUCH
INFORMATION.
S 6. Section 3302 of the public health law is amended by adding a new
subdivision 41 to read as follows:
41. "REGISTRY" OR "PRESCRIPTION MONITORING PROGRAM REGISTRY" MEANS THE
PRESCRIPTION MONITORING PROGRAM REGISTRY ESTABLISHED PURSUANT TO SECTION
THIRTY-THREE HUNDRED FORTY-THREE-A OF THIS ARTICLE.
S 7. This act shall take effect one year after it shall have become a
law; provided, however, that:
(a) the commissioners of health and education are authorized to add,
amend or repeal any rule or regulation necessary and take other action
necessary for the implementation of such provisions on such effective
date;
(b) prior to such effective date, to the extent practicable, the
department of health shall authorize practitioners, pharmacists and
designees to access the prescription monitoring registry as set forth in
this act and shall permit such access prior to such effective date, to
the extent practicable; and
(c) nothing in subdivision (b) of this section shall require a practi-
tioner to consult the registry prior to the effective date of this act.
PART B
Section 1. Sections 270 through 276 and section 277 of article 2-A of
the public health law are designated title I and a new title heading is
added to read as follows:
PREFERRED DRUG AND CLINICAL DRUG REVIEW PROGRAMS
S 1-a. Sections 276-a and 276-b of article 2-A of the public health
law are renumbered sections 278 and 279, respectively, and such sections
and section 280 of such article are designated title II and a new title
heading is added to read as follows:
PRESCRIPTION DRUGS; VARIOUS PROVISIONS
S 2. Article 2-A of the public health law is amended by adding a new
title III to read as follows:
TITLE III
PRESCRIPTION FORMS, ELECTRONIC PRESCRIBING AND LANGUAGE ASSISTANCE
S. 7637 9
SECTION 281. OFFICIAL NEW YORK STATE PRESCRIPTION FORMS.
S 281. OFFICIAL NEW YORK STATE PRESCRIPTION FORMS. 1. IN ADDITION TO
THE REQUIREMENTS OF SECTION SIXTY-EIGHT HUNDRED TEN OF THE EDUCATION LAW
OR ARTICLE THIRTY-THREE OF THIS CHAPTER, ALL PRESCRIPTIONS WRITTEN IN
THIS STATE BY A PERSON AUTHORIZED BY THIS STATE TO ISSUE SUCH
PRESCRIPTIONS SHALL BE ON SERIALIZED OFFICIAL NEW YORK STATE
PRESCRIPTION FORMS PROVIDED BY THE DEPARTMENT. SUCH FORMS SHALL BE
FURNISHED TO PRACTITIONERS AUTHORIZED TO WRITE PRESCRIPTIONS AND TO
INSTITUTIONAL DISPENSERS, AND SHALL BE NON-REPRODUCIBLE AND NON-TRANS-
FERABLE. THE COMMISSIONER, IN CONSULTATION WITH THE COMMISSIONER OF
EDUCATION, MAY PROMULGATE EMERGENCY REGULATIONS FOR THE ELECTRONIC TRAN-
SMISSION OF PRESCRIPTIONS FROM PRESCRIBERS TO PHARMACISTS OR FOR ORDER-
ING AND FILLING REQUIREMENTS OF PRESCRIPTION DRUGS FOR PRESCRIPTIONS
WRITTEN FOR RECIPIENTS ELIGIBLE FOR MEDICAL ASSISTANCE PURSUANT TO TITLE
ELEVEN OF ARTICLE FIVE OF THE SOCIAL SERVICES LAW, FOR PARTICIPANTS IN
THE PROGRAM FOR ELDERLY PHARMACEUTICAL INSURANCE COVERAGE PURSUANT TO
TITLE THREE OF ARTICLE TWO OF THE ELDER LAW AND FOR PRESCRIPTIONS WRIT-
TEN PURSUANT TO ARTICLE THIRTY-THREE OF THIS CHAPTER. NOTHING IN THIS
SECTION SHALL PROHIBIT THE COMMISSIONER IN CONSULTATION WITH THE COMMIS-
SIONER OF EDUCATION FROM PROMULGATING ANY ADDITIONAL EMERGENCY REGU-
LATIONS IN FURTHERANCE OF THIS SUBDIVISION.
2. THE COMMISSIONER, IN CONSULTATION WITH THE COMMISSIONER OF EDUCA-
TION, SHALL PROMULGATE REGULATIONS REQUIRING THAT PRESCRIPTION FORMS AND
ELECTRONIC PRESCRIPTIONS INCLUDE: (A) A SECTION WHEREIN PRESCRIBERS MAY
INDICATE WHETHER AN INDIVIDUAL IS LIMITED ENGLISH PROFICIENT, AS DEFINED
IN SECTION SIXTY-EIGHT HUNDRED TWENTY-NINE OF THE EDUCATION LAW; AND (B)
IF THE PATIENT IS LIMITED ENGLISH PROFICIENT, A LINE WHERE THE PRESCRI-
BER MAY SPECIFY THE PREFERRED LANGUAGE INDICATED BY THE PATIENT. FAIL-
URE TO INCLUDE SUCH INDICATION ON THE PART OF THE PRESCRIBER SHALL NOT
INVALIDATE THE PRESCRIPTION.
3. ON OR BEFORE DECEMBER THIRTY-FIRST, TWO THOUSAND TWELVE, THE
COMMISSIONER SHALL PROMULGATE REGULATIONS, IN CONSULTATION WITH THE
COMMISSIONER OF EDUCATION, ESTABLISHING STANDARDS FOR ELECTRONIC
PRESCRIPTIONS. NOTWITHSTANDING ANY OTHER PROVISION OF THIS SECTION OR
ANY OTHER LAW TO THE CONTRARY, EFFECTIVE TWO YEARS SUBSEQUENT TO THE
DATE ON WHICH SUCH REGULATIONS ARE PROMULGATED, NO PERSON SHALL ISSUE
ANY PRESCRIPTION IN THIS STATE UNLESS SUCH PRESCRIPTION IS MADE BY ELEC-
TRONIC PRESCRIPTION FROM THE PERSON ISSUING THE PRESCRIPTION TO A PHAR-
MACY IN ACCORDANCE WITH SUCH REGULATORY STANDARDS, EXCEPT FOR
PRESCRIPTIONS: (A) ISSUED BY VETERINARIANS; (B) ISSUED IN CIRCUMSTANCES
WHERE ELECTRONIC PRESCRIBING IS NOT AVAILABLE DUE TO TEMPORARY TECHNO-
LOGICAL OR ELECTRICAL FAILURE, AS SET FORTH IN REGULATION; (C) ISSUED BY
PRACTITIONERS WHO HAVE RECEIVED A WAIVER OR A RENEWAL THEREOF FOR A
SPECIFIED PERIOD DETERMINED BY THE COMMISSIONER, NOT TO EXCEED ONE YEAR,
FROM THE REQUIREMENT TO USE ELECTRONIC PRESCRIBING, PURSUANT TO A PROC-
ESS ESTABLISHED IN REGULATION BY THE COMMISSIONER, IN CONSULTATION WITH
THE COMMISSIONER OF EDUCATION, DUE TO ECONOMIC HARDSHIP, TECHNOLOGICAL
LIMITATIONS THAT ARE NOT REASONABLY WITHIN THE CONTROL OF THE PRACTI-
TIONER, OR OTHER EXCEPTIONAL CIRCUMSTANCE DEMONSTRATED BY THE PRACTI-
TIONER; (D) ISSUED BY A PRACTITIONER UNDER CIRCUMSTANCES WHERE, NOTWITH-
STANDING THE PRACTITIONER'S PRESENT ABILITY TO MAKE AN ELECTRONIC
PRESCRIPTION AS REQUIRED BY THIS SUBDIVISION, SUCH PRACTITIONER REASON-
ABLY DETERMINES THAT IT WOULD BE IMPRACTICAL FOR THE PATIENT TO OBTAIN
SUBSTANCES PRESCRIBED BY ELECTRONIC PRESCRIPTION IN A TIMELY MANNER, AND
SUCH DELAY WOULD ADVERSELY IMPACT THE PATIENT'S MEDICAL CONDITION,
PROVIDED THAT IF SUCH PRESCRIPTION IS FOR A CONTROLLED SUBSTANCE, THE
S. 7637 10
QUANTITY OF CONTROLLED SUBSTANCES DOES NOT EXCEED A FIVE DAY SUPPLY IF
THE CONTROLLED SUBSTANCE WERE USED IN ACCORDANCE WITH THE DIRECTIONS FOR
USE; OR (E) ISSUED BY A PRACTITIONER TO BE DISPENSED BY A PHARMACY
LOCATED OUTSIDE THE STATE, AS SET FORTH IN REGULATION.
4. IN THE CASE OF A PRESCRIPTION FOR A CONTROLLED SUBSTANCE ISSUED BY
A PRACTITIONER UNDER PARAGRAPH (B) OF SUBDIVISION THREE OF THIS SECTION,
THE PRACTITIONER SHALL FILE INFORMATION ABOUT THE ISSUANCE OF SUCH
PRESCRIPTION WITH THE DEPARTMENT AS SOON AS PRACTICABLE, AS SET FORTH IN
REGULATION.
5. IN THE CASE OF A PRESCRIPTION FOR A CONTROLLED SUBSTANCE ISSUED BY
A PRACTITIONER UNDER PARAGRAPH (D) OR (E) OF SUBDIVISION THREE OF THIS
SECTION, THE PRACTITIONER SHALL, UPON ISSUING SUCH PRESCRIPTION, FILE
INFORMATION ABOUT THE ISSUANCE OF SUCH PRESCRIPTION WITH THE DEPARTMENT
BY ELECTRONIC MEANS, AS SET FORTH IN REGULATION.
6. THE WAIVER PROCESS ESTABLISHED IN REGULATION PURSUANT TO PARAGRAPH
(C) OF SUBDIVISION THREE OF THIS SECTION SHALL PROVIDE THAT A PRACTI-
TIONER PRESCRIBING UNDER A WAIVER MUST NOTIFY THE DEPARTMENT IN WRITING
PROMPTLY UPON GAINING THE CAPABILITY TO USE ELECTRONIC PRESCRIBING, AND
THAT A WAIVER SHALL TERMINATE WITHIN A SPECIFIED PERIOD OF TIME AFTER
THE PRACTITIONER GAINS SUCH CAPABILITY.
S 3. Section 6810 of the education law is amended by adding four new
subdivisions 10, 11, 12 and 13 to read as follows:
10. NOTWITHSTANDING ANY OTHER PROVISION OF THIS SECTION OR ANY OTHER
LAW TO THE CONTRARY, EFFECTIVE TWO YEARS SUBSEQUENT TO THE DATE ON WHICH
REGULATIONS ESTABLISHING STANDARDS FOR ELECTRONIC PRESCRIPTIONS ARE
PROMULGATED BY THE COMMISSIONER OF HEALTH, IN CONSULTATION WITH THE
COMMISSIONER PURSUANT TO SUBDIVISION THREE OF SECTION TWO HUNDRED EIGHT-
Y-ONE OF THE PUBLIC HEALTH LAW, NO PRACTITIONER SHALL ISSUE ANY
PRESCRIPTION IN THIS STATE, UNLESS SUCH PRESCRIPTION IS MADE BY ELEC-
TRONIC PRESCRIPTION FROM THE PRACTITIONER TO A PHARMACY, EXCEPT FOR
PRESCRIPTIONS: (A) ISSUED BY VETERINARIANS; (B) ISSUED OR DISPENSED IN
CIRCUMSTANCES WHERE ELECTRONIC PRESCRIBING IS NOT AVAILABLE DUE TO
TEMPORARY TECHNOLOGICAL OR ELECTRICAL FAILURE, AS SET FORTH IN REGU-
LATION; (C) ISSUED BY PRACTITIONERS WHO HAVE RECEIVED A WAIVER OR A
RENEWAL THEREOF FOR A SPECIFIED PERIOD DETERMINED BY THE COMMISSIONER OF
HEALTH, NOT TO EXCEED ONE YEAR, FROM THE REQUIREMENT TO USE ELECTRONIC
PRESCRIBING, PURSUANT TO A PROCESS ESTABLISHED IN REGULATION BY THE
COMMISSIONER OF HEALTH, IN CONSULTATION WITH THE COMMISSIONER DUE TO
ECONOMIC HARDSHIP, TECHNOLOGICAL LIMITATIONS THAT ARE NOT REASONABLY
WITHIN THE CONTROL OF THE PRACTITIONER, OR OTHER EXCEPTIONAL CIRCUM-
STANCE DEMONSTRATED BY THE PRACTITIONER; (D) ISSUED BY A PRACTITIONER
UNDER CIRCUMSTANCES WHERE, NOTWITHSTANDING THE PRACTITIONER'S PRESENT
ABILITY TO MAKE AN ELECTRONIC PRESCRIPTION AS REQUIRED BY THIS SUBDIVI-
SION, SUCH PRACTITIONER REASONABLY DETERMINES THAT IT WOULD BE IMPRACTI-
CAL FOR THE PATIENT TO OBTAIN SUBSTANCES PRESCRIBED BY ELECTRONIC
PRESCRIPTION IN A TIMELY MANNER, AND SUCH DELAY WOULD ADVERSELY IMPACT
THE PATIENT'S MEDICAL CONDITION, PROVIDED THAT IF SUCH PRESCRIPTION IS
FOR A CONTROLLED SUBSTANCE, THE QUANTITY THAT DOES NOT EXCEED A FIVE DAY
SUPPLY IF THE CONTROLLED SUBSTANCE WAS USED IN ACCORDANCE WITH THE
DIRECTIONS FOR USE; OR (E) ISSUED BY A PRACTITIONER TO BE DISPENSED BY A
PHARMACY LOCATED OUTSIDE THE STATE, AS SET FORTH IN REGULATION.
11. IN THE CASE OF A PRESCRIPTION ISSUED BY A PRACTITIONER UNDER PARA-
GRAPH (B) OF SUBDIVISION TEN OF THIS SECTION, THE PRACTITIONER SHALL BE
REQUIRED TO FILE INFORMATION ABOUT THE ISSUANCE OF SUCH PRESCRIPTION
WITH THE DEPARTMENT OF HEALTH AS SOON AS PRACTICABLE, AS SET FORTH IN
REGULATION.
S. 7637 11
12. IN THE CASE OF A PRESCRIPTION ISSUED BY A PRACTITIONER UNDER PARA-
GRAPH (D) OR (E) OF SUBDIVISION TEN OF THIS SECTION, THE PRACTITIONER
SHALL, UPON ISSUING SUCH PRESCRIPTION, FILE INFORMATION ABOUT THE ISSU-
ANCE OF SUCH PRESCRIPTION WITH THE DEPARTMENT OF HEALTH BY ELECTRONIC
MEANS, AS SET FORTH IN REGULATION.
13. THE WAIVER PROCESS ESTABLISHED IN REGULATION PURSUANT TO PARAGRAPH
(C) OF SUBDIVISION TEN OF THIS SECTION SHALL PROVIDE THAT A PRACTITIONER
PRESCRIBING UNDER A WAIVER MUST NOTIFY THE DEPARTMENT IN WRITING PROMPT-
LY UPON GAINING THE CAPABILITY TO USE ELECTRONIC PRESCRIBING, AND THAT A
WAIVER SHALL TERMINATE WITHIN A SPECIFIED PERIOD OF TIME AFTER THE PRAC-
TITIONER GAINS SUCH CAPABILITY.
S 4. Section 21 of the public health law is REPEALED.
S 5. This act shall take effect immediately; provided, however, that
the provisions of subdivision 2 of section 281 of the public health law,
as added by section two of this act, shall take effect March 30, 2013,
except that as of such date, the commissioner of health, the commission-
er of education and the state board of pharmacy are immediately author-
ized and directed to take actions necessary to implement such provisions
as of such date; provided, further, that any rules or regulations that
have been adopted or proposed prior to the effective date of this act
which are applicable to section 21 of the public health law shall now
apply to section 281 of the public health law as added by section two of
this act; and provided, further, that any rules or regulations that have
been adopted or proposed prior to the effective date of this act which
are applicable to sections 276-a and 276-b of the public health law
shall now apply to section 278 and 279 of the public health law, respec-
tively, renumbered by section one-a of this act.
PART C
Section 1. Paragraph 1 of subdivision (b) of schedule II of section
3306 of the public health law, as amended by chapter 457 of the laws of
2006, is amended to read as follows:
(1) Opium and opiate, and any salt, compound, derivative, or prepara-
tion of opium or opiate, excluding apomorphine, dextrorphan, nalbuphine,
nalmefene, naloxone, and naltrexone, and their respective salts, but
including the following:
1. Raw opium.
2. Opium extracts.
3. Opium fluid.
4. Powdered opium.
5. Granulated opium.
6. Tincture of opium.
7. Codeine.
8. Ethylmorphine.
9. Etorphine hydrochloride.
10. Hydrocodone (ALSO KNOWN AS DIHYDROCODEINONE).
11. Hydromorphone.
12. Metopon.
13. Morphine.
14. Oxycodone.
15. Oxymorphone.
16. Thebaine.
17. Dihydroetorphine.
18. ORIPAVINE.
S. 7637 12
S 2. Schedule II of section 3306 of the public health law is amended
by adding a new subdivision (b-1) to read as follows:
(B-1) UNLESS SPECIFICALLY EXCEPTED OR UNLESS LISTED IN ANOTHER SCHED-
ULE, ANY MATERIAL, COMPOUND, MIXTURE, OR PREPARATION CONTAINING ANY OF
THE FOLLOWING, OR THEIR SALTS CALCULATED AS THE FREE ANHYDROUS BASE OR
ALKALOID, IN LIMITED QUANTITIES AS SET FORTH BELOW:
(1) NOT MORE THAN THREE HUNDRED MILLIGRAMS OF DIHYDROCODEINONE (HYDRO-
CODONE) PER ONE HUNDRED MILLILITERS OR NOT MORE THAN FIFTEEN MILLIGRAMS
PER DOSAGE UNIT, WITH A FOURFOLD OR GREATER QUANTITY OF AN ISOQUINOLINE
ALKALOID OF OPIUM.
(2) NOT MORE THAN THREE HUNDRED MILLIGRAMS OF DIHYDROCODEINONE (HYDRO-
CODONE) PER ONE HUNDRED MILLILITERS OR NOT MORE THAN FIFTEEN MILLIGRAMS
PER DOSAGE UNIT, WITH ONE OR MORE ACTIVE NONNARCOTIC INGREDIENTS IN
RECOGNIZED THERAPEUTIC AMOUNTS.
S 3. Section 3307 of the public health law is amended by adding a new
subdivision 5 to read as follows:
5. THE COMMISSIONER SHALL ESTABLISH MINIMUM STANDARDS FOR THE STORAGE,
REPORTING, ORDERING AND RECORD KEEPING OF CONTROLLED SUBSTANCES SPECI-
FIED IN SUBDIVISION (B-1) OF SCHEDULE II OF SECTION THIRTY-THREE HUNDRED
SIX OF THIS ARTICLE BY MANUFACTURERS AND DISTRIBUTORS AS IF SUCH
SUBSTANCES WERE SET FORTH IN SCHEDULE III OF SECTION THIRTY-THREE
HUNDRED SIX OF THIS ARTICLE.
S 4. Paragraph 6 of subdivision (b) of schedule II of section 3306 of
the public health law is REPEALED.
S 5. Subdivision (c) of schedule II of section 3306 of the public
health law is amended by adding a new paragraph 28 to read as follows:
(28) TAPENTADOL.
S 6. Subdivision (d) of schedule II of section 3306 of the public
health law, as added by chapter 664 of the laws of 1985, paragraph 5 as
added by chapter 178 of the laws of 2010, is amended to read as follows:
(d) Stimulants. Unless specifically excepted or unless listed in
another schedule, any material, compound, mixture, or preparation which
contains any quantity of the following substances having a stimulant
effect on the central nervous system, INCLUDING ITS SALTS, ISOMERS, AND
SALTS OF ISOMERS:
(1) Amphetamine[, its salts, optical isomers, and salts of its optical
isomers].
(2) Methamphetamine[, its salts, isomers, and salts of its isomers].
(3) Phenmetrazine [and its salts].
(4) Methylphenidate.
(5) Lisdexamfetamine.
S 7. Subdivision (g) of schedule II of section 3306 of the public
health law is amended by adding a new paragraph 3 to read as follows:
(3) IMMEDIATE PRECURSOR TO FENTANYL:
(I) 4-ANILINO-N-PHENETHYL-4-PIPERIDINE (ANPP).
S 8. Subdivision (h) of schedule II of section 3306 of the public
health law, as amended by chapter 178 of the laws of 2010, is amended to
read as follows:
(h) Anabolic steroids. Unless specifically excepted or unless listed
in another schedule, "anabolic steroid" shall mean any drug or hormonal
substance, chemically and pharmacologically related to testosterone
(other than estrogens, progestins, corticosteroids and dehydroepiandros-
terone) [that promotes muscle growth, or any material, compound,
mixture, or preparation which contains any amount of the following
substances] AND INCLUDES:
(1) 3{beta}, 17-dihydroxy-5a-androstane.
S. 7637 13
(2) 3{alpha}, 17{beta}-dihydroxy-5a-androstane.
(3) 5{alpha}-androstan-3,17-dione.
(4) 1-androstenediol (3{beta},17{beta}-dihydroxy-5{alpha}-androst-1-
ene).
(5) 1-androstenediol (3{alpha},17{beta}-dihydroxy-5{alpha}-androst-1-
ene).
(6) 4-androstenediol (3{beta}, 17{beta}-dihydroxy-androst-4-ene).
(7) 5-androstenediol (3{beta}, 17{beta}-dihydroxy-androst-5-ene).
(8) 1-androstenedione ({5{alpha}}-androst-1-en-3,17-dione).
(9) 4-androstenedione (androst-4-en-3,17-dione).
(10) 5-androstenedione (androst-5-en-3,17-dione).
(11) Bolasterone (7{alpha},17{alpha}-dimethyl-17{beta}-hydroxyandrost-
4-en-3-one).
(12) Boldenone (17{beta}-hydroxyandrost-1, 4,-diene-3-one).
(13) BOLDIONE (ANDROSTA-1,4-DIENE-3,17-DIONE).
(14) Calusterone (7{beta}, 17{alpha}-dimethyl-17{beta}-hydroxyandrost-
4-en-3-one).
[(14)] (15) Clostebol (4-chloro-17{beta}-hydroxyandrost-4-en-3-one).
[(15)] (16) Dehydrochloromethyltestosterone [(4-chloro-17{beta}-
hydroxy-17{alpha}-methyl-androst-1] (4-CHLORO-17{BETA}-HYDROXY-17
{ALPHA}-METHYL-ANDROST-1, 4-dien-3-one).
[(16)] (17) {Delta} 1-dihydrotestosterone (a.k.a. '1-testosterone')
(17 {beta}-hydroxy-5{alpha}-androst-1-en-3-one).
[(17)] (18) 4-dihydrotestosterone (17{beta}-hydroxy-androstan-3-one).
[(18)] (19) Drostanolone (17{beta}-hydroxy-2{alpha}-methyl-5{alpha}
-androstan-3-one).
[(19)] (20) Ethylestrenol (17{alpha}-ethyl-17{beta}-hydroxyestr-
4-ene).
[(20)] (21) Fluoxymesterone (9-fluoro-17{alpha}-methyl-11{beta}, 17
{beta}-[dihydroxandrost]DIHYDROXYANDROST-4-en-3-one).
[(21)] (22) Formebolone (2-formyl-17{alpha}-methyl-11{alpha},
17{beta}-dihydroxyandrost-1, 4-dien-3-one).
[(22)] (23) Furazabol (17{alpha}-methyl-17{beta}-hydroxyandrostano
{2, 3-c}-furazan).
[(23) 13{beta}-ethyl-17{alpha}-hydroxygon-4-en-3-one]
(24) 13{BETA}-ETHYL-17{BETA}-HYROXYGON-4-EN-3-ONE.
[(24)] (25) 4-hydroxytestosterone [(4,17 {beta}-dihydroxyandrost-4-
en-3-one)] (4, 17{BETA}-DIHYDROXY-ANDROST-4-EN-3-ONE).
[(25)] (26) 4-hydroxy-19-nortestosterone
(4,17{beta}-dihydroxy-estr-4-en-3-one).
[(26)] (27) DESOXYMETHYLTESTOSTERONE
(17{ALPHA}-METHYL-5{ALPHA}-ANDROST-2-EN-17{BETA}-OL) (A.K.A., MADOL).
(28) Mestanolone (17{alpha}-methyl-17{beta}-hydroxy-
5-androstan-3-one).
[(27)] (29) Mesterolone (1{alpha}[-]methyl-17{beta}-hydroxy-
{5{alpha}}-androstan-3-one).
[(28)] (30) Methandienone (17{alpha}-methyl-17{beta}-hydroxyandrost-1,
4-dien-3-one).
[(29)] (31) Methandriol (17{alpha}-methyl-3{beta},
17{beta}-dihydroxyandrost-5-ene).
[(30)] (32) Methenolone (1-methyl-17{beta}-hydroxy-5{alpha}-androst-
1-en-3-one).
[(31)] (33) 17{alpha}-methyl-3{beta},17{beta}-dihydroxy-5a-androstane.
[(32)] (34) 17{alpha}-methyl-3{alpha}, 17{beta}-dihydroxy-
5a-androstane.
[(33)] (35) 17{alpha}-methyl-3{beta}, 17{beta}-dihydroxyandrost-4-ene.
S. 7637 14
[(34)] (36) 17{alpha}-methyl-4-hydroxynandrolone (17{alpha}-methyl-4-
hydroxy-17{beta}-hydroxyestr-4-en-3-one).
[(35)] (37) Methyldienolone (17{alpha}-methyl-17{beta}-hydroxyestra-
4,9(10)-dien-3-one).
[(36)] (38) Methyltrienolone
(17{alpha}-methyl-17{beta}-hydroxyestra-4, 9-11-trien-3-one).
[(37)] (39) Methyltestosterone
(17{alpha}-methyl-17{beta}-hydroxyandrost- 4-en-3-one).
[(38)] (40) Mibolerone
(7{alpha},17{alpha}-dimethyl-17{beta}-hydroxyestr- 4-en-3-one).
[(39)] (41) 17{alpha}-methyl-{Delta} 1-dihydrotestosterone
(17b{beta}-hydroxy-17{alpha}-methyl-5{alpha}-androst-1-en-3-one)
(a.k.a. '17-{alpha}-methyl-1-testosterone').
[(40)] (42) Nandrolone(17{beta}-hydroxyestr-4-en-3-one).
[(41)] (43) 19-nor-4-androstenediol (3{beta},17{beta}-dihydroxyestr
-4-ene).
[(42)] (44) 19-nor-4-androstenediol (3{alpha},17{beta}-dihydroxyestr-
4-ene).
[(43)] (45) 19-nor-5-androstenediol (3{beta},17{beta}-dihydroxyestr
-5-ene).
[(44)] (46) 19-nor-5-androstenediol (3{alpha},17{beta}-dihydroxyestr-
5-ene).
[(45)] (47) 19-NOR-4,9(10)-ANDROSTADIENEDIONE
(ESTRA-4,9(10)-DIENE-3,17-DIONE).
(48) 19-nor-4-androstenedione (estr-4-en-3,17-dione).
[(46)] (49) 19-nor-5-androstenedione (estr-5-en-3,17-dione).
[(47)] (50) Norbolethone (13{beta}, 17{alpha}-diethyl-17{beta}
-hydroxygon-4-en-3-one).
[(48)] (51) Norclostebol (4-chloro-17{beta}-hydroxyestr-4-en-3-one).
[(49)] (52) Norethandrolone (17{alpha}-ethyl-17{beta}-hydroxyestr-
4-en-3-one).
[(50)] (53) Normethandrolone (17{alpha}-methyl-17{beta}
-hydroxyestr-4-en-3-one).
[(51)] (54) Oxandrolone (17{alpha}-methyl-17{beta}-hydroxy-2-oxa-
{5{alpha}}-androstan-3-one).
[(52)] (55) Oxymesterone (17{alpha}-methyl-4, 17{beta}-dihydroxy[-]
androst-4-en-3-one).
[(53)] (56) Oxymetholone (17 {alpha}-methyl-2-hydroxymethylene-17
{beta}-hydroxy-{5{alpha}}- androstan-3-one).
[(54)] (57) Stanozolol (17{alpha}-methyl-17{beta}-hydroxy-{5{alpha}}-
androst-2-eno{3, 2-c}-pyrazole).
[(55)] (58) Stenbolone (17{beta}-hydroxy-2-methyl-{5{alpha}}-androst-
1-en-3-one).
[(56)] (59) Testolactone (13-hydroxy-3-oxo-13, 17-secoandrosta-1,
4-dien-17-oic acid lactone).
[(57)] (60) Testosterone (17{beta}-hydroxyandrost-4-en-3-one).
[(58)] (61) Tetrahydrogestrinone (13{beta}, 17{alpha}-diethyl
-17{beta}-hydroxygon-4, 9, 11-trien-3-one).
[(59)] (62) Trenbolone (17{beta}-hydroxyestr-4, 9, 11-trien-3-one).
[(60)] (63) Any salt, ester or ether of a drug or substance described
or listed in this subdivision.
S 9. The opening paragraph of subdivision (c) of schedule III of
section 3306 of the public health law, as added by chapter 664 of the
laws of 1985, is amended to read as follows:
Unless specifically excepted or unless listed in another schedule, any
material, compound, mixture, or preparation which contains any quantity
S. 7637 15
of the following substances having a depressant effect on the central
nervous system, INCLUDING ITS SALTS, ISOMERS, AND SALTS OF ISOMERS:
S 10. Subdivision (e) of schedule III of section 3306 of the public
health law, as added by chapter 664 of the laws of 1985, paragraphs 3
and 4 as amended by chapter 589 of the laws of 1996 and paragraph 9 as
added by chapter 457 of the laws of 2006, is amended to read as follows:
(e) Narcotic drugs. Unless specifically excepted or unless listed in
another schedule, any material, compound, mixture, or preparation
containing any of the following narcotic drugs, or their salts calcu-
lated as the free anhydrous base or alkaloid, in limited quantities as
set forth below:
(1) Not more than 1.8 grams of codeine per one hundred milliliters or
not more than ninety milligrams per dosage unit, with an equal or great-
er quantity of an isoquinoline alkaloid of opium.
(2) Not more than 1.8 grams of codeine per one hundred milliliters or
not more than ninety milligrams per dosage unit, with one or more
active, nonnarcotic ingredients in recognized therapeutic amounts.
(3) [Not more than three hundred milligrams of dihydrocodeinone
(hydrocodone) per one hundred milliliters or not more than fifteen
milligrams per dosage unit, with a fourfold or greater quantity of an
isoquinoline alkaloid of opium.
(4) Not more than three hundred milligrams of dihydrocodeinone (hydro-
codone) per one hundred milliliters or not more than fifteen milligrams
per dosage unit, with one or more active nonnarcotic ingredients in
recognized therapeutic amounts.
(5)] Not more than 1.8 grams of dihydrocodeine per one hundred milli-
liters or not more than ninety milligrams per dosage unit, with one or
more active nonnarcotic ingredients in recognized therapeutic amounts.
[(6)] (4) Not more than three hundred milligrams of ethylmorphine per
one hundred milliliters or not more than fifteen milligrams per dosage
unit, with one or more active, nonnarcotic ingredients in recognized
therapeutic amounts.
[(7)] (5) Not more than five hundred milligrams of opium per one
hundred milliliters or per one hundred grams or not more than twenty-
five milligrams per dosage unit, with one or more active, nonnarcotic
ingredients in recognized therapeutic amounts.
[(8)] (6) Not more than fifty milligrams of morphine per one hundred
milliliters or per one hundred grams, with one or more active, nonnar-
cotic ingredients in recognized therapeutic amounts.
[(9)] (7) Buprenorphine in any quantities.
S 11. Subdivision (f) of schedule III of section 3306 of the public
health law, as amended by chapter 178 of the laws of 2010, is amended to
read as follows:
(f) [(i)] Dronabinol (SYNTHETIC) in sesame oil and encapsulated in a
soft gelatin capsule in a [drug product approved for marketing by the]
U.S. Food and Drug Administration [(FDA)] APPROVED PRODUCT.
[(ii) Any drug product in tablet or capsule form containing natural
dronabinol derived from the cannabis (plant) or synthetic dronabinol
(produced from synthetic materials) for which an abbreviated new drug
application (ANDA) has been approved by the FDA under section 505(j) of
the Federal Food, Drug, and Cosmetic Act which references as its listed
drug the drug product referred to in paragraph (i) of this subdivision.]
Some other names for dronabinol include: (6aR-trans)-6a, 7, 8, 10a-tet-
rahydro-6, 6, 9-trimethyl-3-pentyl-6H-dibenzo{b,d} pyran-1-o1, or
(-)-delta-9-(trans) - tetrahydrocannabinol.
S. 7637 16
S 12. Subdivision (c) of schedule IV of section 3306 of the public
health law is amended by adding two new paragraphs 52 and 53 to read as
follows:
(52) FOSPROPOFOL.
(53) CARISOPRODOL.
S 13. Paragraph 11 of subdivision (e) of schedule IV of section 3306
of the public health law, as added by chapter 457 of the laws of 2006,
is amended to read as follows:
(11) [Modafanil] MODAFINIL.
S 14. Subdivision (f) of schedule IV of section 3306 of the public
health law is amended by adding a new paragraph 3 to read as follows:
(3) TRAMADOL IN ANY QUANTITIES.
S 15. Subdivision (b) of schedule V of section 3306 of the public
health law, as added by chapter 664 of the laws of 1985, is amended to
read as follows:
(b) Narcotic drugs containing nonnarcotic active medicinal ingredi-
ents. Any compound, mixture, or preparation containing any of the
following narcotic drugs, or their salts calculated as the free anhyd-
rous base or alkaloid, in limited quantities as set forth below, which
shall include one or more nonnarcotic active medicinal ingredients in
sufficient proportion to confer upon the compound, mixture, or prepara-
tion valuable medicinal [qualitites] QUALITIES other than those
possessed by narcotic drugs alone:
(1) Not more than two hundred milligrams of codeine per one hundred
milliliters or per one hundred grams.
(2) Not more than one hundred milligrams of dihydrocodeine per one
hundred milliliters or per one hundred grams.
(3) Not more than one hundred milligrams of ethylmorphine per one
hundred milliliters or per one hundred grams.
(4) Not more than 2.5 milligrams of diphenoxylate and not less than
twenty-five micrograms of atropine sulfate per dosage unit.
(5) Not more than one hundred milligrams of opium per one hundred
milliliters or per one hundred grams.
(6) Not more than 0.5 milligram of difenoxin and not less than twen-
ty-five micrograms of atropine sulfate per dosage unit.
S 16. Subdivision (d) of schedule V of section 3306 of the public
health law, as added by chapter 178 of the laws of 2010, is amended to
read as follows:
(d) Depressants. Unless specifically exempted or excluded or unless
listed in another schedule, any material, compound, mixture, or prepara-
tion which contains any quantity of the following substances having a
depressant effect on the central nervous system, including its salts,
ISOMERS, AND SALTS OF ISOMERS:
(1) EZOGABINE {N-{2-AMINO-4-(4-FLUOROBENZYLAMINO)-PHENYL}-CARBAMIC
ACID ETHYL ESTER}.
(2) LACOSAMIDE {(R)-2-ACETOAMIDO-N-BENZYL-3-METHOXY-PROPIONAMIDE}.
(3) Pregabalin [(]{(S)-3-(aminomethyl)-5-methylhexanoic acid[)]}.
S 17. Subdivision 7 of section 3331 of the public health law, as
amended by chapter 640 of the laws of 1990, is amended to read as
follows:
7. A practitioner may not administer, prescribe or dispense any
substance referred to in subdivision (h) [or subdivision (j)] of Sched-
ule II, AND SUBDIVISION (G) OF SCHEDULE III, of section three thousand
three hundred six of this article for other than therapeutic purposes. A
practitioner may not administer, prescribe or dispense any such
substance to any individual without first obtaining the informed consent
S. 7637 17
of such individual, or where the individual lacks capacity to give such
consent, a person legally authorized to consent on his or her behalf.
S 18. Subdivision 8 of section 220.00 of the penal law, as amended by
chapter 664 of the laws of 1985, is amended to read as follows:
8. "Narcotic preparation" means any controlled substance listed in
schedule II(B-1), III(d) or III(e).
S 19. This act shall take effect on the ninetieth day after it shall
have become a law; provided that sections two, three, ten, fourteen and
eighteen shall take effect on the one hundred eightieth day after it
shall have become a law; and provided that sections fifteen and seven-
teen of this act shall take effect immediately.
PART D
Section 1. Subparagraphs (i), (ii) and (iii) of paragraph (b) of
subdivision 2 of section 3309-a of the public health law, as added by
section 52 of part D of chapter 56 of the laws of 2012, are amended and
a new subparagraph (iv) is added to read as follows:
(i) Report to the commissioner regarding the development of recommen-
dations and model courses for continuing medical education, refresher
courses and other training materials for licensed health care profes-
sionals on appropriate use of prescription pain medication. Such recom-
mendations, model courses and other training materials shall be submit-
ted to the commissioner, who shall make such information available for
the use in medical education, residency programs, fellowship programs,
and for use in continuing medication education programs no later than
January first, two thousand thirteen. SUCH RECOMMENDATIONS ALSO SHALL
INCLUDE RECOMMENDATIONS ON: (A) EDUCATIONAL AND CONTINUING MEDICAL
EDUCATION REQUIREMENTS FOR PRACTITIONERS APPROPRIATE TO ADDRESS
PRESCRIPTION PAIN MEDICATION AWARENESS AMONG HEALTH CARE PROFESSIONALS;
(B) CONTINUING EDUCATION REQUIREMENTS FOR PHARMACISTS RELATED TO
PRESCRIPTION PAIN MEDICATION AWARENESS; AND (C) CONTINUING EDUCATION IN
PALLIATIVE CARE AS IT RELATES TO PAIN MANAGEMENT, FOR WHICH PURPOSE THE
WORK GROUP SHALL CONSULT THE NEW YORK STATE PALLIATIVE CARE EDUCATION
AND TRAINING COUNCIL;
(ii) No later than January first, two thousand thirteen, provide
outreach and assistance to health care professional organizations to
encourage and facilitate continuing medical education training programs
for their members regarding appropriate prescribing practices FOR THE
BEST PATIENT CARE and the risks associated with [prescription] OVERPRES-
CRIBING AND UNDERPRESCRIBING pain medication; [and]
(iii) Provide information to the commissioner for use in the develop-
ment and continued update of the public awareness campaign, including
information, resources, and active web links that should be included on
the website[.]; AND
(IV) CONSIDER OTHER ISSUES DEEMED RELEVANT BY THE COMMISSIONER,
INCLUDING HOW TO PROTECT AND PROMOTE THE ACCESS OF PATIENTS WITH A
LEGITIMATE NEED FOR CONTROLLED SUBSTANCES, PARTICULARLY MEDICATIONS
NEEDED FOR PAIN MANAGEMENT BY ONCOLOGY PATIENTS, AND WHETHER AND HOW TO
ENCOURAGE OR REQUIRE THE USE OR SUBSTITUTION OF OPIOID DRUGS THAT EMPLOY
TAMPER-RESISTANCE TECHNOLOGY AS A MECHANISM FOR REDUCING ABUSE AND
DIVERSION OF OPIOID DRUGS.
S 2. Subdivision 3 of section 3309-a of the public health law, as
added by section 52 of part D of chapter 56 of the laws of 2012, is
amended to read as follows:
S. 7637 18
3. ON OR BEFORE SEPTEMBER FIRST, TWO THOUSAND TWELVE, THE COMMISSION-
ER, IN CONSULTATION WITH THE COMMISSIONER OF THE OFFICE OF ALCOHOLISM
AND SUBSTANCE ABUSE SERVICES, THE COMMISSIONER OF EDUCATION, AND THE
EXECUTIVE SECRETARY OF THE STATE BOARD OF PHARMACY, SHALL ADD TO THE
WORKGROUP SUCH ADDITIONAL MEMBERS AS APPROPRIATE SO THAT THE WORKGROUP
MAY PROVIDE GUIDANCE IN FURTHERANCE OF THE IMPLEMENTATION OF THE I-STOP
ACT. FOR SUCH PURPOSES, THE WORKGROUP SHALL INCLUDE BUT NOT BE LIMITED
TO CONSUMER ADVISORY ORGANIZATIONS, HEALTH CARE PRACTITIONERS AND
PROVIDERS, ONCOLOGISTS, ADDICTION TREATMENT PROVIDERS, PRACTITIONERS
WITH EXPERIENCE IN PAIN MANAGEMENT, PHARMACISTS AND PHARMACIES, AND
REPRESENTATIVES OF LAW ENFORCEMENT AGENCIES.
4. The commissioner shall report to the governor, the temporary presi-
dent of the senate and the speaker of the assembly no later than March
first, two thousand thirteen, and annually thereafter, on the work
group's findings. The report shall include information on opioid over-
dose deaths, emergency room utilization for the treatment of opioid
overdose, the utilization of pre-hospital addiction services and recom-
mendations to reduce opioid addiction and the consequences thereof. THE
REPORT SHALL ALSO INCLUDE A RECOMMENDATION AS TO WHETHER SUBDIVISION TWO
OF SECTION THIRTY-THREE HUNDRED FORTY-THREE-A OF THIS ARTICLE SHOULD BE
AMENDED TO REQUIRE PRACTITIONERS PRESCRIBING OR DISPENSING CERTAIN IDEN-
TIFIED SCHEDULE V CONTROLLED SUBSTANCES TO COMPLY WITH THE CONSULTATION
REQUIREMENTS OF SUCH SUBDIVISION.
S 3. This act shall take effect immediately.
PART E
Section 1. The public health law is amended by adding a new section
3343-b to read as follows:
S 3343-B. SAFE DISPOSAL OF UNUSED CONTROLLED SUBSTANCES. THE DEPART-
MENT SHALL ESTABLISH A PROGRAM FOR THE SAFE DISPOSAL OF UNUSED
CONTROLLED SUBSTANCES BY CONSUMERS IN ACCORDANCE WITH FEDERAL LAW. THE
PROGRAM SHALL PERMIT INDIVIDUAL MEMBERS OF THE PUBLIC TO VOLUNTARILY
SURRENDER CONTROLLED SUBSTANCES LISTED ON SCHEDULE II, III, IV OR V OF
SECTION THIRTY-THREE HUNDRED SIX OF THIS ARTICLE IN A SECURE MANNER,
WITHOUT IDENTIFYING THEMSELVES, AND SHALL BE PUBLICIZED CONSISTENT WITH
THE PRESCRIPTION PAIN MEDICATION AWARENESS PROGRAM ESTABLISHED PURSUANT
TO SECTION THIRTY-THREE HUNDRED NINE-A OF THIS ARTICLE. THE SURRENDER OF
A CONTROLLED SUBSTANCE PURSUANT TO THE PROGRAM ESTABLISHED PURSUANT TO
THIS SECTION SHALL NOT CONSTITUTE THE POSSESSION, TRANSFER OR SALE OF
SUCH CONTROLLED SUBSTANCE FOR PURPOSES OF THIS ARTICLE OR THE PENAL LAW.
IN DEVELOPING SUCH PROGRAM, THE DEPARTMENT SHALL CONSIDER THE FOLLOWING:
APPROPRIATE SITES FOR DISPOSAL THROUGHOUT THE STATE; THE ROLE OF LAW
ENFORCEMENT AND FEDERAL AUTHORITIES, AS APPROPRIATE; AND THE MANNER IN
WHICH POTENTIAL COSTS TO LOCALITIES OR TO THE STATE WILL BE ADDRESSED.
DISPOSAL SITES SHALL BE OPERATED BY LAW ENFORCEMENT AGENCIES ON A VOLUN-
TARY BASIS IN COLLABORATION WITH THE DEPARTMENT. NOTHING IN THIS
SECTION SHALL REQUIRE ANY POLITICAL SUBDIVISION OF THE STATE TO PARTIC-
IPATE IN THE PROGRAM ESTABLISHED IN THIS SECTION.
S 2. This act shall take effect immediately.
S 3. Severability clause. If any clause, sentence, paragraph, subdivi-
sion, section or part of this act shall be adjudged by any court of
competent jurisdiction to be invalid, such judgment shall not affect,
impair or invalidate the remainder thereof, but shall be confined in its
operation to the clause, sentence, paragraph, subdivision, section or
part thereof directly involved in the controversy in which such judgment
S. 7637 19
shall have been rendered. It is hereby declared to be the intent of the
legislature that this act would have been enacted even if such invalid
provisions had not been included herein.
S 4. This act shall take effect immediately; provided, however, that
the applicable effective date of Parts A through E of this act shall be
as specifically set forth in the last section of such Parts.
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