Relates to the sale, delivery, dispensing and/or distribution of controlled substances

Section 2 of the bill adds new PHL §§ 3302(34), (35), (36), (37), (38), (39) and 40 to define terms pertaining to Internet transactions.

Section 3 of the bill adds new PHL § 3335 to clarify that online dispensers must comply with PHL Article 33 and must submit information about the dispensing of controlled substances by means of the Internet to the Department of Health (DOH) by electronic means.

Section 4 of the bill amends PHL § 3371(1) to make technical changes.

Section 5 of the bill adds new PHL § 3371-a to authorize DOH to share information about prescription controlled substances with authorized controlled substance regulatory agencies in other states under defined circumstances and for specified purposes.

Section 6 of the bill amends PHL §§ 3331(6) to maintain the existing requirement that information regarding the dispensing of controlled substances be filed electronically with DOH, subject to DOH regulations, but eliminate the statutory requirement that the information be filed within a particular time period.

Section 7 of the bill amends PHL § 3332 to authorize health care practitioners to prescribe controlled substances by electronic means and describe the information that must be included in such electronic prescription. such as the name and address of both the practitioner and the patient and the date of prescription.

Section 8 of the bill amends PHL § 3333 to authorize pharmacies to dispense controlled substances prescribed electronically. The section maintains the requirement that the pharmacy electronically file prescription information with DOH regarding the dispensing of controlled substances but eliminates the requirement that the information be filed within a particular time period. As specified in several places throughout the bill, electronic prescriptions would have to be consistent with federal requirements.

Section 9 of the bill amends PHL § 3370 to require that electronic prescription records be maintained as required by regulations of the Commissioner of Health.

Sections 10 and 11 of the bill make technical conforming amendments to PHL §§ 3334 and 3337 to reflect the new statutory scheme for the electronic prescribing and dispensing of controlled substances.

Section 12 of the bill amends PHL 3381 to authorize electronic prescriptions for hypodermic needles and syringes and to authorize a pharmacist to endorse his or her electronic signature upon an electronic prescription for hypodermic needles and syringes. Section 12 of the bill also authorizes a pharmacist to dispense hypodermic needles and syringes to patients in nursing homes pursuant to a patient-specific prescription form as permitted under Education Law § 6810(7)(b). The bill will also have the effect of allowing the transfer of a needle and syringe prescription from one pharmacy to another for purposes of dispensing a refill.

Sections 13 through 18 of the bill amend PHL § 3306 by updating the controlled substance schedules to ensure inclusion of all federally scheduled substances.

Section 19 of the bill amends PHL § 3352 to delete the requirement that a Methadone Maintenance Treatment Program (MMTP) file a monthly report with DOH summarizing all methadone activity from the previous month, while retaining the requirement that instances of theft, loss or possible diversion of controlled substances be immediately reported. The section also removes a reference to Article 23 of the Mental Hygiene Law (MHL), which was repealed a number of years ago.

Section 20 of the bill provides that the bill will take effect immediately, except that §§ 3 and 19 will take effect 180 days after the bill's enactment and §§ 13 through 18 will take effect 90 days after the bill's enactment. Section 20 of the bill also grants immediate authority to the Department to add, amend, or repeal regulations necessary for the implementation of the legislation, and states that any provisions providing for or addressing the provision of electronic prescriptions shall not take effect unless and until such electronic prescriptions for controlled substances are specifically permitted by the federal government.

Existing law

PHL § 3302 sets forth definitions applicable to PHL Article 33.

PHL § 3306 establishes five schedules listing controlled substances. Schedule 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.

PHL § 3308 authorizes DOH to promulgate regulations regarding the prescribing, dispensing, use and transmission of electronic prescriptions.

PHL § 3331(6) requires practitioners that dispense controlled substances to file information related to such dispensing with DOH by electronic means.

PHL § 3332 provides that prescriptions for controlled substances can only be made in writing on an official New York State prescription form.

PHL § 3333(4) requires pharmacies to file information related to the dispensing of controlled substances with DOH by electronic means.

PHL §§ 3334 and 3337 authorize oral prescriptions for controlled substances in both emergency and non-emergency situations, so long as a written prescription is delivered to the dispensing pharmacy within 72 hours.

PHL § 3338 authorizes the prescribing and dispensing of controlled substances pursuant to electronic prescriptions, in accordance with regulations of the Commissioner.

PHL § 3352 requires MMTPs to maintain records showing the receipt, administration, dispensing, or destruction of all controlled substances to submit monthly reports of methadone activity to DOH, including information about thefts or losses.

PHL § 3371 authorizes DOH to notify a practitioner when a person under his or her treatment with controlled substances also may be under treatment with controlled substances by another practitioner.

PHL § 3370 requires the maintenance of records concerning prescription controlled substances.

PHL § 3381 concerns the sale and possession of hypodermic syringes and hypodermic needles. Certain sections of the version of § 3381 that is currently in effect will be replaced by a second version on September 1, 2011, pursuant to Chapter 56 of the Laws of 2000.

MHL §§ 32.05 and 32.09 require operating certificates for MMTPs.

Title 10, § 80.73(f) of the New York Codes, Rules and Regulations (NYCRR) requires that records of prescriptions for controlled substances be electronically transmitted to DOH in a format acceptable to DOH.

The regulations of the State Education Department at 8 NYCRR 63.6(a)(7) permit electronic prescriptions for non-controlled substances, as long as the transmission of a prescription from a prescriber to a pharmacy is secured through electronic encryption.

Title 42, Part 160 of the Code of Federal Regulations requires health care providers that transmit protected health information electronically to encrypt such transmissions.

Legislative history

A.11690/S.8185-A, which contained most of the components included in this bill, passed the Senate but not the Assembly in 2008. A.10666-A/S.8186-A, which contained the provision on MMTPs, passed the Assembly but not the Senate in 2008.

Statement in support

A. Sharing of Information with Authorized Out-of-State Entities

This bill will allow DOH to provide official prescription information to authorized controlled substance regulatory agencies in other states. Providing this information will curtail prescription drug diversion by individuals engaging in drug seeking activity in multiple states. The legislation will also make New York eligible for millions of dollars in federal funding available under a federal law entitled the National All Schedules Prescription Electronic Reporting (NASPER). The purpose of NASPER is to curtail drug diversion through the establishment and enhancement of prescription monitoring programs and through the sharing of prescription monitoring program data between states. This bill will allow DOH to share official Prescription data with authorized agencies from other states which agree to comply with DOH standards, including adherence to strict security, authentication of information, and strict confidentiality of data.

B. Electronic Prescriptions for Controlled Substances

An estimated 15 to 20 percent of all paper prescriptions are fraudulent. Electronic prescribing is a secure method of transmitting prescriptions from practitioners to pharmacists and curtails prescription fraud because an electronic prescription cannot be physically altered, forged, or stolen by individuals attempting to divert controlled substances for addiction and illegal sale. Equally important, 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 attributed to misinterpretations of written prescriptions. In addition to the unnecessary loss of life, medication errors are estimated to cost the nation's health care system over 870 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 8130 million.

Part 63.6(a)(7) of the State Education Commissioner's regulations currently allows prescriptions for non-controlled substances to be electronically transmitted from a practitioner to a pharmacy. provided the transmission is secured through electronic encryption. PHL § 3338 currently authorizes the prescribing and dispensing of controlled substances pursuant to electronic prescriptions in accordance with DOH regulations. which require that such prescriptions be transmitted in a transmission format acceptable to DOH Similarly. PHL § 3308 authorizes DOH to promulgate regulations regarding the prescribing, dispensing, use and transmission of electronic prescriptions. This legislation makes clarifications to this existing, statutory authority to promote the electronic prescribing and dispensing of controlled substances.

In promoting electronic prescriptions for controlled substances, the bill preserves certain existing safeguards, such as the provision that no more than a 30-day supply of a controlled substance may be dispensed in conjunction with an electronic prescription, unless the prescription indicates that such period is authorized under DOH regulations. In addition, the bill requires that any controlled substance dispensed in accordance with an electronic prescription be labeled in a specific manner, which mirrors the requirements already in existence for nonelectronic prescriptions for controlled substances. This will clarify and conform the existing statutory authority in PHL §§ 3308 and 3338 for dispensing of electronic prescriptions for controlled substances. The authority to issue electronic prescriptions for controlled substances is contingent upon changes to federal law.

C. Prescriptions for Hypodermic Needles and Syringes

The Public Health Law currently requires a pharmacist to dispense a hypodermic needle and syringe only pursuant to a "written" prescription (an official New York State prescription) of a practitioner. This requirement precludes an electronic prescription for needles and syringes or the ability of a pharmacy to transfer a prescription for needles and syringes to another pharmacy for dispensing of a refill to a patient in need who may be in a different location. The "written" prescription requirement also precludes the dispensing of needles and syringes by pharmacists to patients in nursing homes pursuant to a patient-specific prescription form (a medical order), which is permitted under the Education Law.

The bill's deletion of "written" from PHL § 3381(1)(a) means that a prescription under PHL § 3302(31) will include an electronic prescription, which will authorize the prescribing and dispensing of needles and syringes, including those prefilled with non-controlled substance medications, pursuant to an electronic prescription. This change will also authorize a pharmacy to transfer a prescription for needles and syringes, including those prefilled with non-controlled substance medications, to another pharmacy for the dispensing of a refill as authorized by regulations of the Commissioner of Education.

In addition, by amending PHL § 3381(1)(a) to include the patient-specific prescription form as provided under Education Law § 6810(7)(b), pharmacists will be able to dispense needles and syringes, including those prefilled with.non-controlled substance medications, to patients in nursing homes pursuant to a medical order, on which. all the patients' other non-controlled substance medications are dispensed. This saves the practitioner from being required to issue a separate official prescription just for the needles and syringes.

These amendments will greatly enhance patient care and provide for more efficient and timely dispensing for those patients requiring hypodermic needles and syringes necessary to administer their medications.

D. Updating Controlled Substance Schedules

Entries on the State schedules are not the same as those that appear on the five federal schedules of controlled substances (21 U.S.C. § 801). Chapter 457 of the Laws of 2007 made conforming changes that brought the Article 33 schedules closer to the federal schedules, but they still are not identical. 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. For example, DOH is aware of increasing diversion and abuse of the pain reliever pregabalin, a federal Schedule V controlled substance not defined as a controlled substance by State law. Analysis of prescription information reveals that numerous individuals who seek controlled substances from multiple practitioners also seek prescriptions for pregabalin. Including all federally-scheduled controlled substances on the New York State schedule will address these Raps.

In 2006, the United States Drug Enforcement Agency (DEA) updated its definition of anabolic steroids in conjunction with the Anabolic Steroid Control Act of 2004. This federal law was enacted to prevent abuse of anabolic steroids by professional athletes and to address widespread abuse of anabolic steroids and their precursors by college, high school, and middle school students. The law added 59 additional steroids and their precursors to the list of anabolic steroids defined as controlled substances and closed a loophole exploited by anabolic steroid traffickers, who were marketing steroid precursors (steroid substances that are converted to anabolic steroids in the body) and designer steroids (steroid substances containing a minor chemical modification) as dietary supplements. Such dietary supplements have the same effect in the body as anabolic steroids and were readily available in health food stores without a prescription. Bringing the New York State scheduling and definition of anabolic steroids into conformity with federal scheduling will curtail illegal sale of these dangerous drugs marketed as dietary supplements.

E. Methadone Treatment Programs

Current law requires MMTPs to submit monthly records of methadone activity to DOH. This is unnecessary. The Office of Alcohol and Substance Abuse Services (OASAS) registers and regulates MMTPs in New York and requires that they comply with specific recordkeeping requirements regarding methadone usage. Specifically. OASAS requires MMTP records to include signed physician orders and to document the administration, dispensing, and receipt of methadone by authorized persons. MMTPs must document the amount of methadone they use each day and must complete a report documenting a daily inventory of narcotics on hand. The rigorous accountability demanded by OASAS obviates the need for DOH to receive monthly MMTP records of methadone usage. However, it will still be necessary for an MMTP to immediately notify DOH in the event of the loss, theft, or possible diversion of controlled substances.

Budget implications

This bill is not anticipated to have a fiscal impact on the State, except that electronic prescribing will reduce the number of prescriptions written on official New York State prescription forms. which are paid for by the State.

Effective date

This bill will take effect immediately, except that §§ 3 and 19 will take effect 180 days after the bill's enactment and §§ 13 through 18 will take effect 90 days after the bill's enactment. Any provisions providing for or addressing the provision of electronic prescriptions will not take effect unless and until such electronic prescriptions for controlled substances are specifically permitted by the federal government.