United States: New I-Stop Controlled Substance Registry Deadline Rapidly Approaching

Last Updated: August 12 2013
Article by Rachel A. Fernbach and Benjamin Geizhals

Starting August 27, 2013, all practitioners in New York (including physicians, dentists, podiatrists and nurse practitioners) will be required to consult a new online state registry designed to track the prescription and dispensing of controlled substances. The Internet System for Tracking Over-Prescribing Act, a state law enacted in August 2012 and known as I-STOP, establishes a new Prescription Monitoring Program for all Schedule II, III and IV controlled substances. Under this new law, all New York practitioners must consult the new online registry prior to prescribing or dispensing any controlled substance listed in chedule II, III or IV and must also document their actions. This new requirement goes nto effect on August 27, 2013.

NEW DUTY TO CONSULT

  • The Prescription Monitoring Program (PMP) will permit practitioners to review their patients' controlled substance history to determine if a new or renewed prescription for a controlled substance would be appropriate and to prevent fraudulent activity in connection with the use of controlled substances.
  • Prescribing information will be reported to the PMP by pharmacies and will be available on a real time basis, i.e., no more than 48 hours old, and will go back six months in the past.
  • Practitioners must consult the PMP no more than 24 hours prior to issuing a prescription for a controlled substance or dispensing a controlled substance.
  • The new duty to consult applies only to controlled drugs included in New York State Schedules II, III and IV, including opiates and other pain medications, stimulants, barbiturates and sleep aids, among others.
  • Practitioners may designate a non-licensed individual who works for them to search the registry on their behalf.
  • The duty to consult does not apply to veterinarians, methadone programs, institutional dispensers (provided the medication is to be consumed entirely on premises), hospice care, hospital emergency rooms (limited to a five day supply) or to practitioners who administer controlled substances. Other exceptions to the duty to consult include: (i) in the event a practitioner or other designee cannot access the registry in a timely manner, limited to a five day supply; (ii) where consultation of the registry would adversely impact a patient's medical condition, limited to a five day supply and (iii) if the registry is not operational or if the practitioner experiences temporary technological or electrical failure.
  • Failure to consult the PMP will be considered willful misconduct and may result in fines, criminal penalties and filing of OPMC professional misconduct charges. At the same time, however, the statute provides that no practitioner or designee acting with reasonable care and in good faith will be subject to any civil liability arising from any false, incomplete or inaccurate information submitted to or reported by the registry or for any resulting failure of the system to accurately or timely report such information.

HOW TO SIGN UP TO CHECK THE PMP

In order to access the PMP registry, all practitioners must first establish an individual Health Commerce System (HCS) Account and obtain a user ID and password. HCS accounts are established by the NYS Department of Health and may be obtained by applying online at https://hcsteamwork1.health.state.ny.us/pub/top.html . Once you arrive at the linked location, click on "Apply for an HCS Medical Professions Account." The application process includes both an online form and a paper form, which must be notarized. The Department of Health has indicated that it takes approximately two weeks to establish an account, so all practitioners are advised to initiate the application process as soon as possible to be ready for the August 27th compliance deadline. For assistance in obtaining an HCS account, practitioners may contact the Commerce Accounts Management Unit at: 1-866-529-1890.

HOW TO CHECK THE REGISTRY STARTING AUGUST 27, 2013

1. Access the Health Commerce System at: https://commerce.health.state.ny.us

2. Log onto the system with your user ID and password, click on Applications and select Prescription Monitoring Program Registry

In order to search the registry, practitioners must enter in the patient's first name, last name, date of birth and gender. The PMP will include two categories of search results, one entitled "My Prescriptions" and one entitled "Other's Prescriptions." The search results will include the name of the drug, the date of the prescription, the name of any other prescribers, payment method and the pharmacy name and location.

DOCUMENTATION REQUIREMENTS AND OTHER CHANGES

In mid-June of this year, the Department of Health issued proposed regulations implementing the I-STOP statute. The proposed regulations require practitioners to document in the patient record that they consulted the PMP as well as any legitimate eason for failing to consult, including a description of the circumstances that made consultation of the PMP impractical or created adverse consequences.

In addition to the duty to consult, the I-STOP statute also mandates a statewide move to mandatory electronic prescribing starting in 2015, minor revisions to the controlled substance schedules, new continuing education programs on pain management and prescription medication, and the establishment of a new safe disposal program for controlled substances.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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