I-STOP for Pharmacists

New York’s Internet System for Tracking Over Prescribing (I-STOP) legislation that, among other things, mandates prescribing practitioners to consult with the prescription monitoring registry (Registry) prior to prescribing a controlled substance, will go into effect on August 27, 2013. Below we discuss some of the I-STOP implications for pharmacists.

Authority to Consult the Registry

Unlike prescribing practitioners, pharmacists now may–but are not mandated–to consult the Registry prior dispensing a controlled substance. Such access would give pharmacists patients’ controlled substance history and provide additional information to pharmacists who may have concerns about the legitimacy of a prescription. The new law requires that the Registry include for each person to whom a prescription for controlled substances has been dispensed patient information covering a period of time of not less than 6 months and no more than 5 years.

Prior to the passage of this law, while pharmacists had a duty to report controlled substance dispensing, they had no access to the Registry.

The new law permits pharmacists to authorize another pharmacist or a pharmacy intern to consult the Registry on the pharmacist’s behalf, provided that such person is employed by the pharmacy or is under contract with such pharmacy. The law also instructs the Commissioner to establish additional rules with regard to such pharmacist’s delegation of access to the Registry.

Real Time Reporting

I-STOP requires pharmacists to file prescription information “by electronic means on a real time basis” and leaves it up to the Commissioner to define “real time basis.”  Proposed legislation is currently pending that would amend 10 NYCRR 80.71(e) to define the “real time” requirement as the filing of information regarding controlled substances with the Department of Health via the Bureau of Narcotic Enforcement within 24 hours of the substance being delivered.*  Existing regulations require that pharmacists submit dispensing information not later than the 15th day of the next month following the month in which the substance was delivered.

The proposed rule would also allow the Commissioner to issue a late-filing waiver based upon a showing of economic hardship, technological limitations that are not reasonably within the control of the pharmacy or practitioner, or the presence of other exceptional circumstance.

Under the proposed rule, pharmacies delivering prescriptions by mail or licensed express delivery services would be required to file the prescription information not later than 72 hours after the substance was shipped from the pharmacy.

These proposed regulations would also require, when applicable, pharmacies and dispensing practitioners to file a zero report, which is a report that no controlled substances were dispensed by a pharmacy or dispensing practitioner during the relevant period of time. A zero report would be required no later than 14 days following the most recent previously reported dispensing of a controlled substance, the submission of a prior zero report, or the termination of a waiver of the requirement to file a zero report. A waiver of the requirement to file a zero report could be issued by the commissioner based upon a showing that a pharmacy or practitioner does not dispense controlled substances within the state of New York.

These proposed regulations also provide for the sharing of confidential patient information with other select entities including the deputy attorney general for the Medicaid fraud control unit, local health departments, medical examiners or coroners, and to an individual (to provide the individual his or her own controlled substance history) and law enforcement under certain circumstances.

The comment period for the proposed legislation closed on August 5, 2013.

Health Commerce System Account

In order to access the Registry, each pharmacist must have an individual Health Commerce System (HCS) account.

*Update: The notice of adoption of the proposed regulation will be published in the NY State Register on August 21, 2013.  The amended rule becomes effective August 27, 2013.

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