New York’s New I-STOP Prescription Law

Provider Alert: New York has a series of drug prescription requirements that impact medical, dental and pharmaceutical providers. We highlight those provisions below in chronological order.

New Language Assistance Requirements on Official NYS Prescription Form

Effective March 30, 2013, the Official New York State prescription forms will include a section where providers are now required to indicate whether an individual is limited English proficient as well as the language preferred by the individual. Providers can still use forms ordered prior to March 30 and indicate on the front the prescription the requirements of the new law. A prescription missing the language indication, however, will not invalidate it. (PHL 281; 10 NYCRR 910.2).

Any pharmacy that is part of a group of eight or more pharmacies, located within New York state and owned by the same corporate entity must now, among other things, provide free, competent oral interpretation and translation services to each limited English proficient individual requesting such services or filling a prescription that indicates that the individual is limited English proficient. These services would be provided for purposes of counseling, when soliciting information necessary to maintain a patient medication profile and prescription labels unless the individual is offered and refuses such services. Translation services may be provided by a member of the pharmacy’s staff or a third-party contractor.

Internet System For Tracking Over Prescribing (I-STOP) Requirements

On August 27, 2012, Gov. Cuomo signed into law (S.N. 7637) the I-STOP bill aimed at curbing abuses of controlled substances by revamping the State’s DOH Prescription Monitoring Registry (Registry), formerly known as the Controlled Substance Information program (CSI), and imposing new requirements on practitioners. The new law creates an online, real-time database to report and track both the prescribing and the dispensing of certain controlled substances.

The lawmakers’ legislative provided, in part, 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.

As such, starting on August 27, 2013, every practitioner whose license permits the prescribing of Schedule II, III, or IV drugs must consult the Registry prior to prescribing or dispensing for purposes of reviewing a patient’s controlled substance history and make an appropriate notation in the patient’s medical record. Certain practitioners, such as, for example, those administering a controlled substance, are exempt from this requirement. The law also permits practitioners to authorize another designated person to access the Registry, provided that the practitioner remains ultimately responsible for the decision to prescribe a controlled substance.

Prior to dispensing a controlled substance, pharmacies are allowed, but are not required, to consult the Registry.

The Registry will contain patient specific information regarding prescribed controlled substances covering a period of minimum six months and a maximum of five years reported by a pharmacists on a real-time basis or a practitioner who directly dispenses controlled substances to patients.

Importantly, the DOH will periodically analyze the Registry to identify information that indicates that a violation of law or breach of professional standards may have occurred.

Practitioners who have yet to sign up with the Registry at the department’s Health Commerce System (HCS) website are encouraged to do so before the August deadline. Even if practitioners have previously ordered their official NYS prescription forms from HCS via paper format, they must establish an on-line account to access the Registry for purposes of this law.

Phasing Out Paper Prescriptions

Part of the I-STOP law is the phasing out of paper prescriptions in New York. As of March 27, 2015, all prescriptions, not just for controlled substances, will have to be transmitted electronically to a pharmacy.

Compliance with the new law is not discretionary and failure to abide by the new requirements may have a deleterious effect on practitioners’ licenses.

If you have a question about the new legislation or have other questions about pharmacy law or healthcare law, please contact us here.