MEMORANDUM

MEDICAL SOCIETY OF THE STATE OF NEW YORK

99 WASHINGTON AVENUE, SUITE 408, ALBANY, NY 12210

518-465-8085 • Fax: 518-465-0976 • E-mail: albany@mssny.org

I-STOP Law- “Duty To Consult” Provision Effective August 27, 2013

The I-STOP bill, Chapter 447, Laws of 2012 was signed into law on August 27, 2012. This law requires the creation of a “real time” prescription tracking system to provide enhanced information to prescribers and pharmacists concerning prescriptions obtained by patients for controlled substances.

The existing prescription monitoring registry will be enhanced to include information about dispensed controlled substances reported by pharmacies on a “real time” basis (to be defined in regulation) unlike current law where pharmacies must report on the 15th of the month following the month in which the prescription was dispensed. The law specifically prohibits funding of the operation of the database by fees imposed on prescribers.

Beginning August 27, 2013, prescribers will have a duty to consult the database prior to prescribing Schedule II, III and IV controlled substances. Additionally, pharmacists will have access to the registry (which they do not currently).

Importantly, as a result of MSSNY advocacy, prescribers may delegate the responsibility to consult the database to a member of their office staff recognizing that the prescriber remains ultimately responsible for confidentiality of information.

There are several exceptions to the “duty to consult”. The duty to consult does not apply to:

  • Veterinarians;
  • Dispensing methadone or such other controlled substance designated by the commissioner as appropriate for such use may be ordered for use of an addict by a practitioner and dispensed or administered by a practitioner or his designated agent as interim treatment for an addict on a waiting list for admission to an authorized maintenance program.
  • The controlled substance is being administered in the prescriber’s office;
  • Prescribing or ordering a controlled substance for use within an institution (hospital or clinic);
  • The prescription is being written in an emergency room setting and is for no more than a five day supply of medication;
  • The prescription is being written for a hospice patient;
  • Not reasonably possible to access the registry in a timely manner, where there is no other practitioner or designee reasonably available to access the database, and supply is limited to 5 days
  • Where consultation of the registry would result in a patient’s inability to obtain a prescription in a timely manner, thereby adversely impacting the patient’s medical condition (acting in compliance with regulations to be developed by Health Commissioner);
  • Practitioner who has been granted a waiver due to technological limitations not within the control of the practitioner, or other exceptional circumstance demonstrated by the practitioner pursuant to a process established in regulation by Health Commissioner; and
  • Where the registry is not operational or cannot be accessed due to a temporary technological or electrical failure.

MSSNY advocacy is credited for the addition of many of these exceptions.

I-STOP mandates electronic submission of ALL prescription by March 27, 2015. The Commissioner of Health has established regulations for this process, including waiver requirements. The law requires that the prescription drug registry be compatible with the electronic transmission of prescriptions for controlled substances. It specifically states that to the extent practicable, implementation of the electronic transmission of prescription for controlled substances shall serve to streamline consultation of the registry by practitioner.

The law contains several exceptions to the e-prescribing mandate including:

  • Prescriptions issued by veterinarians;
  • Prescriptions issued in circumstances where e-prescribing is not available due to a temporary and technological failure;
  • Prescriptions issued by practitioners who have received a waiver or a renewal of a waiver for a period not to exceed one year, from the requirement to use electronic prescribing, pursuant to a process established in regulation by the commissioner of health, in consultation with the commissioner due to economic hardship, technological limitations that are not reasonably within the control of the practitioner, or other exceptional circumstance demonstrated by the practitioner;
  • Where prescriber reasonably determines that e-prescribing would make it impractical for the patient to receive the needed medication, adversely impacting the patient’s medical condition, provided the script is no for no more than a 5-day supply; and
  • Where the prescription is going to an out of state pharmacy.

The law now requires the official state prescription forms to be modified by March 30, 2013 to include a section where a prescriber may indicate whether an individual is limited English proficient and also include a line for the prescriber to specify the preferred language of the patient. Failure to include this indication shall not invalidate the prescription.

On February 23, 2013, Hydrocodone was moved to Schedule II controlled substance and Tramadol added to Schedule IV list of controlled substances.

The composition and scope of authority of the DOH Work Group on Prescription Pain Medication Awareness created earlier this year is expanded by I-STOP to include making recommendations on:

  • Continuing education for prescribers and pharmacists on pain management issues;
  • Protecting patient access to controlled substances;
  • Implementation of the I-Stop provisions;
  • The inclusion of additional controlled substances to the list for which a duty to consult will apply; and
  • Consider other issues deemed relevant by the commissioner, including how to protect and promote the access of patients with a legitimate need for controlled substances, particularly medications needed for pain management by oncology patients, and whether and how to encourage or require the use or substitution of opioid drugs that employ tamper-resistance technology.

The Work Group is authorized under the new law to include the addition of other healthcare practitioners and providers including oncologists, addiction medicine practitioners and practitioners with experience in pain management. MSSNY has a physician that has been appointed to the Work Group.

Further information may be obtained by contacting Pat Clancy, MSSNY’s Vice President for Public Health and Education at pclancy@mssny.org; or Liz Dears Kent, Esq., Senior Vice President and Chief Legislative Counsel at ldears@mssny.org or by calling them at 518-465-8085.

Updated 5/13/13