This CE activity was originally published in The Rx Consultant. If you received credit for it previously, you cannot receive credit for it again.
2014 was an exciting year for new drug approvals and,according to Forbes, the best since the all-time record in 1996.The FDA approved 44 novel agents: 39 (excluding imaging agents) by the Center for Drug Evaluation and Research (CDER) and 5 (including only recombinant agents) by the Center for Biologics Evaluation and Research (CBER).Seventeen of the CDER approvals are considered first-in-class,and span 10 therapeutic areas led by infectious diseases, cancer, and rare diseases.Three more novel drugs were approved in the first 6 weeks of 2015;2 of the 3 are first-in-class. The increased rate of approvals may be related to the FDA’s effort to ensure that treatments for serious conditions are approved as soon as there is enough evidence that their benefits outweigh their risks. Four expedited programs were established: fast track designation, accelerated approval,priority review, and breakthrough therapy designation.Many of the recently approved drugs took advantage of these approaches.
Given the large number of approvals, The Rx Consultant will publish 2 New Drugs issues this year. The first issue provides detailed reviews of inhaled human insulin,2 weight loss products, 2 products for chronic hepatitis C virus infection, and a first-in-class orexin receptor antagonist for insomnia. Usual doses and selected drug interactions are summarized in Table 1.Eleven more new drugs that are likely to be encountered in everyday practice are described in Table 2.
This CE activity is a monograph (PDF file).
Pharmacists, Nurse Practitioners, Clinical Nurse Specialists, and Registered Nurses
This CE activity was developed by The Rx Consultant, a publication of Continuing Education Network, Inc.
CE activities for Pharmacists and Pharmacy Technicians:
This continuing education (CE) activity meets the requirements of all state boards of pharmacy for approved continuing education hours. CE credit is automatically reported to CPE Monitor.
CE activities for Nurse Practitioners and Clinical Nurse Specialists:
This continuing education activity meets the requirements of:
The American Nurses Credentialing Center (ANCC) for formally approved continuing education (CE) hours, and CE hours of pharmacotherapeutics.
The American Academy of Nurse Practitioners Certification Program (AANPCP) for acceptable, accredited CE.
This is a pharmacotherapeutics/pharmacology CE activity.
The ANCC requires all advanced practice nursing certificants (CNSs and NPs) to complete 25 CE hours of pharmacotherapeutics as a portion of the required 75 continuing education hours.
Pharmacology CE is recommended by the AANPCP and will be required for Certificants renewing certification starting January 2017.
Most State Boards of Nursing require a minimum number of pharmacy contact hours to renew an advanced practice license.
Continuing Education Network, Inc. is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
Requirements for CE Credit
To receive CE credit, the participant must read the monograph in its entirety, complete the online post-test and receive a score of 70% or greater, and complete the online evaluation.
Pharmacists and Pharmacy Technicians -
Be sure your profile has been updated with your NAPB e-profile # and birth date informationBEFORE completing the online evaluation, or your credits cannot be reported to CPE Monitor.
Continuing pharmacy education credit is automatically reported to CPE Monitor once the post-test & evaluation are successfully completed.
For each of the drugs reviewed, list the FDA approved indication(s), discuss the evidence supporting the approval, and discuss the potential role(s) in therapy.
Describe the significant side effects and drug interactions of each of the drugs reviewed. Provide 2-3 patient counseling tips.
For each drug listed in Table 2, List the generic name, brand name if applicable, and FDA approved indication(s).
James Chan, Pharm.D., PhD
Brief Bio : James Chan, PharmD, PhD, Pharmacy Quality and Outcomes Coordinator, Kaiser Permanente, Oakland, CA and Associate Clinical Professor, School of Pharmacy, University of California, San Francisco, CA.
Disclosure : Dr.Chan reports no financial or personal relationships with any commercial interest producing, marketing, reselling, or distributing a product or service that appears in this issue.
Pamela Mausner, MD
Brief Bio : Pamela Mausner, MD,Medical Writer/Editor and Healthcare Advocate.
Disclosure : Dr.Mausner reports no financial or personal relationship with any commercial interest producing, marketing, reselling, or distributing a product or service that appears in this issue.
Tracy Farnen, PharmD
Brief Bio : PharmD, Associate Editor, The Rx Consultant.
Disclosure : Dr. Tracy Farnen reports no financial or personal relationship with any commercial interest producing, marketing, reselling, or distributing a product or service that appears in this issue.