June 26, 2013

Education and Certification Standards for Prescribers and Pharmacists

Education and Certification Standards for Prescribers and Pharmacists
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Prescription drug misuse remains a critical and pervasive health concern that poses unique challenges because of the need to balance prevention, education, and enforcement, with the need for legitimate access to scheduled medications and the protection of patient care. To that end, the workgroup has developed a set of recommendations it believes will support an increase in the knowledge base of practitioners proportional to the potential risks associated with prescribing in addition to the enhancements to the Prescription Drug Monitoring Registry (PDMR). The workgroup acknowledges that the establishment of controls and requirements can present obstacles, but hopes that its efforts will be perceived as reasonable, judicious and efficacious. To that end, the nongovernmental members encourage the state to make funding available to make the required training free to prescribers and pharmacists.

The workgroup also strived to draw from various sources to develop clinical guidance in a number of key areas. While there is consensus that guidance will help to protect the public health, we were unable to agree on approach and metrics. We recommend that the New York State Departments Health and the New York State Education Department convene a panel of experts whose charge would be to develop clinical guidance in the areas referenced above by a date certain. Their work may take into consideration the Risk Evaluation and Mitigation Strategy (REMS), FDA Blue Print for Prescriber Education, as well as, The New York City Health Information “CHI” Preventing Misuse of Prescription Opioid Drugs and Opioid Prescribing Guidelines, Resources for Emergency Department Providers.

We have appreciated the opportunity to contribute to the I-STOP initiative and invite comment and discussion of our recommendations.

Regulatory Recommendations

  • Initial education and subsequent recertification should be mandatory for all prescribers and pharmacists.
  • Initial education for those already licensed should commence with re-registration
  • Education should address all scheduled drugs and can be targeted to practice or specialty.
  • Online education should be available.
  • All education vendors should demonstrate to the consumer that they comply with current content standards established by the state rather than the state approving each curriculum.
  • All prescribers and pharmacists should maintain records of completed education.
  • Prescribers who write more than 100 M.M.E. per day/per patient for any patient should receive a minimum of 8 hours of continuing education. End of life palliative care is exempt.
  • Prescribers who write less than 100 M.M.E. per day/per patient for all patients should receive a minimum of 2 hours of continuing education; including end of life palliative care.
  • One hour recertification education should be mandatory commensurate with each second license renewal unless otherwise stated.
  • A documented practice self audit of a representative sample of prescribing behavior should suffice for renewal.
  • Requirements specific to dentists: Both the 2 and 8 hour continuing education tracks should be incorporated into the existing 60 hours of continuing education for dentists as a one-time requirement taking place at the first license registration period following adoption of these requirements. For new licensees it would take place during the first registration period when the 60 hour continuing education requirement becomes effective.
  • Requirements specific to pharmacists: As a requirement for re-licensure, pharmacists must take 45 hours of continuing education of which 23 hours must be live each three-year cycle. As part of those mandatory CE requirements, pharmacists must take at least one hour of pharmacy law and three hours of patient safety. Pharmacists should dedicate a minimum of 2 hours of live or on-line training that satisfies the content and guidance identified in this recommendation. For new licensees, it would take place during the first registration period when the 45 hours of continuing education requirement becomes effective.
  • Within 2 years of the commencement of the I-STOP software, access to I-Stop should be conditional on attestation of having completed appropriate education and then upon recertification going forward. The 2 year grace period will allow for the development and acquisition of education.
  • SED Office of the Professions with NYSDOH and OASAS should establish a seven member or larger panel of prescribers and pharmacist to approve education program standards.
  • NYSDOH, OASAS and SED Office of the Professions with representative stakeholders should establish outcome measures to determine the success, as well as, unintended outcomes of the I-STOP initiative.

Recommended Content Areas

  • Overview of I-Stop
  • Overview of DEA requirements
  • Pharmacology of scheduled drugs
  • Managing acute pain
  • Managing chronic non-cancer pain
  • Managing addiction
  • Non-opioid pain management
  • Pain, mental health and substance use disorders
  • Dosing and monitoring
  • Patient management
  • Prescribing guidelines
  • Referral to specialty care for pain, mental health and substance use disorders
  • Clinical application of the PDMR
  • Resources for prescribers and pharmacists


Prescriber and Pharmacist Education Workgroup Members

  • Charles Argoff, MD
  • Roland Bojo, RN, BSN, EMT
  • Brenda Breuer, Ph.D
  • Leigh Briscoe-Dwyer, Pharm. D
  • Frank Dowling, MD
  • Lawrence Duda, DDS
  • Mike Duteau, R.Ph
  • Susan Foster, MSW
  • Dennis Galluzzo, RPh
  • Katherine A. Hawkins, MD, JD
  • Steven Kipnis, MD, FACP, FASAM
  • Hillary Kunins, MD
  • Charles Morgan, MD
  • Lewis Nelson, MD
  • Rob Piculell, LMSW
  • Tracy Pugh, MPHA
  • Steven J. Tunick, DMD
  • Norm Wetterau, MD