The recent increase of prescription drug abuse led both chambers of the New York State Legislature to pass the Internet System for Tracking Over-Prescribing (I-STOP) Act on June 11, 2012. The legislation seeks to tighten control over certain controlled substances in an effort to decrease criminal diversion and abuse of such prescription drugs which can result in addiction, violence, family conflicts and increased costs to business and the health care system.
A major focus of the I-STOP Act is the creation of a “real time” Prescription Monitoring Program Registry which is aimed at shrinking the number of fraudulent prescriptions, minimizing doctor-shopping and reducing the over-prescribing of controlled substances. The registry will contain patient history information of no less than six months and no more than five years. Among other things, the registry will contain information including the patient’s name and address, the date the prescription was issued and the date it was dispensed, the metric quantity of drug dispensed, the supply of drug by number of days and the prescriber’s name.
Duty to Check Registry
The legislation imposes a duty upon practitioners to check the registry before prescribing certain controlled substances. Practitioners may designate an employee or contractor to access the registry of their behalf, however, if the following conditions are met: (1) the practitioner takes reasonable steps to ensure that the designee is competent in the use of the registry; (2) the practitioner remains responsible for the designee’s access to the registry, including remaining responsible for any breach of patient confidentiality; and (3) the ultimate decision as to whether or not to prescribe or dispense a controlled substance remains with the practitioner and is reasonably informed by the relevant controlled substance history information obtained from the registry. Practitioners, pharmacists and those persons acting on behalf of practitioners and pharmacists, who act with reasonable care and in good faith, are provided immunity against any civil liability arising from the reliance by such person upon false, incomplete or inaccurate information submitted to or reported by the registry.
There are exceptions to the duty to consult the registry before prescribing certain controlled substances. For example, the duty does not apply to: (1) veterinarians; (2) a practitioner prescribing a controlled substance that is to be administered in the prescriber’s office; (3) a practitioner prescribing a controlled substance for use within an institution such as a hospital or clinic; (4) a practitioner prescribing a controlled substance in an emergency room setting if the prescription is for no more than a five-day supply; (4) practitioners when it is not reasonably possible for the practitioner to access the registry in a timely manner; or (5) practitioners where the registry is not operational or cannot be accessed due to a temporary technological or electrical failure.
E-Prescribing and Other Requirements
In addition to the Prescription Monitoring Program Registry, the legislation also requires that all prescriptions be issued electronically by December 31, 2014, updates New York State’s controlled substance schedules, calls for practitioners to be educated regarding the overprescribing of controlled substances and general pain management and requires the Department of Health to establish a safe disposal program to facilitate consumer disposal of unused medications. The legislation will be sent to Governor Andrew Cuomo, who is expected to sign the legislation into law.