New Drugs 2016 – 2017- Pharmacy Technician

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After a record-setting 45 approvals in 2015, the FDA approved only 22 new molecular entities in 2016. The FDA’s Office of New Drugs gave 3 explanations for the drop off: 1) 5 drugs with 2016 due dates were approved ahead of schedule in 2015; 2) biopharmaceutical companies filed fewer applications in 2016; and 3) there were more rejections. Of the 22 novel drugs, almost one third received breakthrough therapy designation, about two thirds were given priority review, and more than one third were for rare diseases. Two of the novel agents, elbasvir/grazoprevir and sofosbuvir/velpatasvir, were discussed in The Rx Consultant November 2016 issue on hepatitis C. This issue reviews 8 novel drugs: crisaborole – the first topical phosphodiesterase 4 inhibitor for atopic dermatitis; ixekizumab – the second interleukin-17A inhibitor for psoriasis; lifitegrast – a first-in-class ophthalmic agent for dry eye disease; pimavanserin – the first drug to be approved for Parkinson’s disease psychosis; and 4 cancer drugs – atezolizumab for bladder and lung cancer, olaratumab for soft tissue sarcoma, rucaparib for ovarian cancer, and venetoclax for chronic lymphocytic leukemia Prasterone, a new option for a common postmenopausal disorder, is also reviewed. The 4 cancer drugs received accelerated approval; this means that their continued approval may depend on confirmation of benefit in further studies. Usual doses and selected drug interactions are summarized in Table 1. Nine more new drugs or new dosage forms that may be encountered in every day practice are described in Table 2. Both tables include pronunciation guides and brand names...

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Course Information

Target Audience

Tech Drug Therapy

Knowledge Level

General Overview

This activity will apply to a broad range of learning needs/pharmacy settings. It may include common disease state/therapy overivews and/or general pharmacy needs such as medication errors, immunizations, or law topics.

Learning Objectives

Course Accreditation

  • Activity Type:
    Knowledge
  • CE Broker
  • Universal Activity Number:
    Pharmacy Technician : 0428-0000-17-003-H01-T
PharmCon is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

PharmCon, Inc. is an approved course provider for continuing education for nurses by the Florida Board of Nursing. PharmCon is also recognized by the California Board of Nursing as a provider of nursing programs.

In order to obtain a Statement of Credit, attendees must answer poll questions where presented and complete a program evaluation. Attendees may immediately print their Statement of Credit or leave them stored on the website.

Technology Requirements

  • Hardware Requirements
    Standard Windows/Mac System
    iPad or iPhone
    Minimum screen resolution: 1024x768
    Speakers or headphones
  • Software Requirements
    Standard Windows/Mac System
    iPad or iPhone
    Minimum screen resolution: 1024x768
    Speakers or headphones
  • Network Requirements
    Broadband Internet Connection:
    T1, Hi-speed DSL or Cable
    4G cellular connection
Computer sharing is NOT permitted due to accreditation guidelines on activity monitoring. Credit is earned by one user per device.