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Drug Safety Oversight Board Meeting, September 15, 2011

Public Summary

The following is a list of the Drug Safety Communications (DSC) posted since the July 21, 2011 meeting and relayed to the Drug Safety Oversight Board (DSB or Board) via memorandum:

The DSB discussed three topics:

  1. CDER Adoption of USP Monograph Naming Policy
  2. Discuss Safety Issues/Key Messages in DSC for Prescription Sleep Aid
  3. Opioid Risk Evaluation and Mitigation Strategy (REMS) Blueprint and Med Guide

The views expressed by non-CDER employees are those of the individual and not necessarily the opinion of their respective government agency or institution.

CDER Adoption of USP Monograph Naming Policy

The Board heard presentations from Angela G. Long, M.S., Vice President, Office of the CEO, Executive Secretariat, Council of Experts of the United States Pharmacopeia (USP) and Richard Lostritto, Ph.D., Director of Division I, Office of New Drug Quality Assessment, on the Center for Drug Evaluation and Research’s (CDER) implementation of the USP Monograph Naming Policy for Salt Drug Substances in Drug Products and Compounded Preparations (“the monograph naming policy”).

Ms. Long provided an introduction to and history of USP, as well as USP’s role in drug naming. She also described in detail the monograph naming policy which will be official May 1, 2013. Ms. Long also discussed the monograph naming policy’s implementation, including proposed timeline and dissemination of key messages to targeted groups via various formats, and the challenges of implementation. Specifically, titles for drug product monographs submitted prior to the official date of May 1, 2013, will use the name approved by FDA with respect to active moiety/salt nomenclature in the title/strength terminology, except in cases where safety issues are involved or where the relevant manufactures in the United States market agree to a name that conforms to the monograph naming policy. The Nomenclature, Safety, and Labeling Expert Committee will apply the monograph naming policy to drug product titles after May 1, 2013. The policy is provided in General Chapter <1121> Nomenclature and is posted on USP’s website. Minor corrections to the policy are proposed in an update to General Chapter <1121>, which will be published for public comment in January 2012.

Dr. Lostritto provided CDER’s perspective of the monograph naming policy and its implementation process.

The Board discussed the following:

  • Consideration should be given to dosing differences (mg, units) with drugs named by their active moiety versus their salt form. For example, the combination product amlodipine and benazepril hydrochloride tablet has the strength for amlodipine expressed in terms of the active moiety but the strength for benzapril is expressed in terms of the salt.
  • Drug products named with one active moiety but available in multiple salt formulations and whether there will be an impact on prescribing, whether this will be interpreted to indicate/replace therapeutic equivalence, and if there will be any effects on Orange Book listings and drug marketing/promotion. If the salt is clinically relevant, the drug name will include the salt. If the salt is not clinically relevant, multiple products could share the same drug product name; however, this does not mean they are therapeutically equivalent – the Orange Book will differentiate them by listing each salt separately. An example of oxycodone and aspirin tablets was presented.
  • The various interpretations of the phrase “clinically relevant effect” in the definition of “vital information from a clinical perspective.” “Vital information from a clinical perspective” means that the salt has a clinically relevant effect on absorption, metabolism, or excretion which impacts safety and/or efficacy. Determination of clinical relevancy is a review decision.
  • Education for patients on medications that are therapeutically equivalent but may be different in appearance, and may have differences in dosage amounts.
  • Education for prescribers and pharmacists on electronic and handwritten prescriptions to help eliminate potential delay in patients receiving medications because of confusion.
  • Various communication tools and distribution methods to consider as part of the rollout plan.

Discuss Safety Issues/Key Messages in Draft DSC for Prescription Sleep Aid

The Board heard a presentation by Ronald Farkas, MD, PhD, Clinical Team Leader in the Division of Neurology Products (DNP) in CDER regarding prescription sleep aids and risk of next-morning driving impairment.

The Board discussed the following:

  • Impact on next-day driving impairment by prescription sleep aids, and comparison of the drug product’s effect with that of other prescription sleep aids.
  • Driving test requirements for sponsors of prescription sleep aids.
  • Consideration of non-sleep aid prescription and over-the-counter drugs with longer half-lives than prescription sleep aids and their impact on next-day driving.
  • The types of patients included in the driving studies, the contribution of concomitant medications to next-morning driving impairment, and other implications of the driving study results.
  • Communicating a message about using prescription sleep aids wisely/as labeled.

Opioid REMS Blueprint and Med Guide

The Board heard presentations from Theresa Toigo, RPh, MBA, Associate Director for Drug Safety Operations, Office of the Center Director in CDER and Richardae Araojo, PharmD, MS, Acting Director, Division of Medical Policy Programs, Office of Medical Policy Initiatives in CDER providing updates on the Opioid REMS Prescriber Education Program (“the Blueprint”) and Medication Guide (Med Guide).  An overview of the opioid REMS was presented at the March 18, 2010, Board meeting.

The Board discussed the following:

  • Relationship and collaboration with other federal agencies and programs.
  • Sufficient granularity of information and criteria to complete and assess the continuing education program.
  • The focus of the opioid REMS and comparison to other REMS.