Relates to the sale, delivery, dispensing and distribution of controlled substances; repealer

Summary of provisions

Section 1 of the bill would amend Public Health Law (PHL) § 3371 to clarify that DOH is authorized to share official prescription information with certain governmental entities within and outside of DOH. Section 1 would also authorize DOH to notify a pharmacy when a person who has obtained controlled substances from the pharmacy may have also obtained controlled substances from another pharmacy under circumstances that suggest possible drug abuse or diversion, potential harm to the individual or other similar grounds.

Sections 2 through 14 of the bill would amend PHL Article 33 by updating the controlled substance schedules.

Section 15 of the bill provides that § 1 of the bill would take effect 180 days after enactment, with all other provisions taking effect 90 days after enactment, and authorizes the Commissioner of Health to immediately engage in rulemaking as necessary to implement the bill.

Existing law

PHL § 3371 authorizes DOH to disclose certain patient prescription information under limited circumstances to certain DOH staff, regulatory agencies, physicians, and to a central registry established pursuant to Article 33 of the Public Health Law, or pursuant to judicial subpoena or court order in a criminal investigation or proceeding.

PHL § 3306 establishes five schedules listing controlled substances. Schedule I controlled substances may not be prescribed, or, except with DOH approval for research purposes, dispensed, possessed, distributed or administered. Substances listed on Schedules II, III, IV, and V may be prescribed only by authorized practitioners, and otherwise dispensed, possessed or administered by authorized practitioners or, as approved by DOH, researchers.

Legislative history

Chapter 178 of the Laws of 2010 enacted a DOH departmental bill to: (1) enable the use of electronic prescriptions when allowed under federal law, and to require practitioners and pharmacies that sell or dispense controlled substances pursuant to an Internet transaction to electronically report information to DOH; (2) authorize the sharing of official prescription information with authorized controlled substance regulatory agencies in other states; (3) make conforming technical amendments to the existing statutory authority for electronic prescribing and dispensing of controlled substances, consistent with federal requirements; (4) allow electronic prescriptions for hypodermic needles and syringes and allow pharmacists to dispense hypodermic needles and syringes to patients in nursing homes; (5) amend State controlled substance schedules to reflect federal schedules; (6) update reporting requirements for methadone treatment programs; and (7) clarify the circumstances under which physicians could be notified that patients may be seeking controlled substances from other health care providers.

Bills to add mephedrone and methylenedioxypyrovalerone to the controlled substance schedules have been introduced in both houses (A.4769-A/S.3322) and (A.5456) but have not passed.

Statement in support

Under its Official Prescription Program, DOH notifies practitioners when a patient obtains controlled substances from multiple practitioners within a 30-day period, a situation which may indicate potential harm to an individual or possible drug abuse or the criminal diversion of drugs. This bill would similarly enhance efforts to ensure patient safety and curtail the diversion and abuse of controlled substances by authorizing DOH to share information with pharmacies when customers seeking to obtain controlled substances have already obtained controlled substances within a 30-day period. 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 pharmacists that may have concerns of the legitimacy of a prescription or potential diversion.

This bill also would amend PHL § 3306 to update the five controlled substances schedules set forth therein. 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. Entries on the State schedules are not identical to those on the five federal schedules of controlled substances (21 U.S.C. § 801), and 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.

Chapter 178 of the Laws of 2010 made conforming changes that brought the Article 33 schedules closer to the federal schedules, but they still are not identical, particularly given additional changes made subsequent to the enactment of the State law. The amendments made by this bill would address currently existing discrepancies between the state and federal controlled substances schedules, and anticipate other changes that are likely to be made under federal law.

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 Schedule 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.

DOH is aware of increasing diversion and abuse of the muscle relaxant, carisoprodol, which is not currently scheduled federally or in New York State. The Drug Enforcement Agency (DEA) has proposed the placement of carisoprodol in schedule IV of the federal Controlled Substance Act. However, no scheduling actions have been finalized. Reports of carisoprodol abuse have resulted in 18 states classifying it as a controlled substance, as of February 2010. In anticipation of the federal government moving carisoprodol into the schedule IV classification, DOH is proposing that carisoprodol be added to PHL §3306 (c).

Analysis of prescription information reveals that numerous individuals who seek controlled substances from multiple practitioners also seek prescriptions for carisoprodol. According to comments received by the DEA, carisoprodol products are being diverted, abused, misused, and sold on the street and from Internet sites without legitimate prescriptions. Data reported in the National Survey on Drug Use and Health indicates that 2,276,000 U.S. residents aged 12 and older used carisoprodol non-medically at least once in their lifetime. The 2009 New York State Police Toxicology Drug Statistics indicates that almost 200 of the 2,269 cases of driving while ability-impaired (DWAI) related to drug use in 2009 were due to carisoprodol use - an incidence that was higher than other controlled substances such as stimulants, methadone and zolpidem.

The bill also would add mephedrone and methylenedioxypyrovalerone as Schedule I controlled substances. There have been a number of reports from the media and poison control centers that such chemicals, which are available in several types of products available for retail sale and have been actively marketed as bath salts, have had stimulant and hallucinogenic effects which have led to emergency department visits and hospital admissions. Several states have already scheduled these chemicals or have proposed legislation to schedule these chemicals. A bill to add these chemicals to the federal schedule has been introduced in Congress. In anticipation of the enactment of such bill, and because the two chemicals appear to be responsible for deleterious effects in a number of users throughout the county, the bill would include these chemicals on the State's Schedule I list.

Additional changes made by the bill add other substances or otherwise conform the State schedule to the federal schedule.

Budget implications

This bill is not anticipated to have a fiscal impact to the State.

Effective date

This bill would take effect 90 days after enactment, except that section I would take effect 180 days after enactment, and the Commissioner of Health would be authorized to engage in rulemaking as necessary to implement the bill prior to such effective dates.