The I-STOP Act will require practitioners to review a patient’s controlled substance prescription history on an online registry prior to prescribing a controlled substance and to report prescriptions issued for controlled substances for inclusion in the same registry.
On August 27, 2012, Governor Cuomo signed into law the Internet System for Tracking Over-Prescribing (I-STOP) Act in response to concerns over the diversion of controlled substances. I-STOP requires the Commissioner of Health to establish and maintain an electronic Prescription Monitoring Program Registry containing data about controlled substances dispensed to individuals and reported on a real-time basis. The Act will require practitioners to review a patient’s controlled substance prescription history on the Registry prior to prescribing a controlled substance and to report prescriptions issued for controlled substances to the Registry at the time of issuance. The stated goal of I-STOP is to identify and assist those who suffer from addiction to controlled substances and to prevent potential addictions, while enabling physicians to provide prescription medications and other controlled substances to patients who actually need them.
The Registry will include information reported by pharmacies and prescribers on a real-time basis as well as patient-specific data such as:
- The patient’s name
- The patient’s residential address
- The patient’s date of birth
- The patient’s gender
- The date on which the prescription was issued
- The date on which the controlled substance was dispensed
- The metric quantity of the controlled substance dispensed
- The number of days supply of the controlled substances dispensed
- The name of the prescriber
- The prescriber’s identification number
- The name or identifier of the drug that was dispensed
- The payment method.
Information in the database is expected to cover a period of no less than six months or more than five years, as determined by the Commissioner.
I-STOP requires that physicians prescribing a schedule II, III, or IV controlled substance consult the Prescription Monitoring Program Registry and review a patient’s controlled substance history prior to prescribing, with certain limited exceptions. Specifically, the duty to consult the Registry does not apply when a physician is:
- Dispensing methadone, or such other substance designated by the Commissioner of the Department of Health, as part of an interim treatment for an addict on a waiting list for admission to an authorized maintenance program
- Administering a controlled substance
- Prescribing or ordering a controlled substance for use on the premises of an institutional dispenser (e.g., a hospital or nursing home)
- Prescribing up to a five-day supply of a controlled substance in a hospital emergency department
- Prescribing a controlled substance to a hospice patient
- Not reasonably able to access the Registry (personally or through his or her designee) in a timely manner and no more than a five-day supply of the controlled substance has been prescribed
- Acting in compliance with regulations promulgated by the Commissioner relating to circumstances that would result in a patient’s inability to obtain a prescription in a timely manner.
Physicians will also be required to issue prescriptions electronically, and when electronic prescribing is not available or may endanger the patient, to file information about the prescription with the Department of Health. To help minimize administrative burdens on practitioners, I-STOP permits physicians to designate another person employed by or under contract with their practices to access information from the Registry on behalf of the physician.
Physicians and their designees who comply with the provisions of I-STOP are provided immunity from civil liability for any false, incomplete or inaccurate information submitted to or reported by the Registry for those who act reasonably and in good faith.
The requirement to consult the Registry prior to prescribing a controlled substance will become effective August 27, 2013. The requirement for electronic prescribing will become effective two years after the NYS Department of Health promulgates regulations establishing standards for electronic prescribing. Regulations for electronic prescribing are anticipated by the end of 2012.