In 2018, the US Food and Drug Administration (FDA) approved 59 new drugs – the highest number in more than 10 years – including 19 first-in-class agents.
Of the 59 new approvals, 73% received priority review. This issue of The Rx Consultant focuses on the new drugs that may be important additions (including a number of “firsts”) in their therapeutic areas: influenza infection, HIV-1 infection, pneumonia and skin infections, nonmetastatic, castration-resistant prostate cancer, endometriosis, migraine prophylaxis, moderate to severe acne, and chronic, idiopathic constipation.
Dosing and drug interactions are detailed in Table 1. Brief descriptions of selected additional new drugs are shown in Table 2, and new HIV drugs and HIV drug combinations are decribed in Table 3. Table 4 lists selected new formulations or indications for previously approved drugs.
- Pharmacists, Nurse Practitioners, Clinical Nurse Specialists, and Registered Nurses
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.
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.
- 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.
Requirements for CE Credit
- For each of the drugs reviewed: 1. List the FDA approved indication(s), state the recommended dose(s), and discuss the evidence supporting the drug’s approval and potential role(s) in therapy.
- 2. Describe significant side effects and drug interactions. Provide 2-3 patient counseling tips.
- For drugs listed in Tables 2 and 3: 3. List the generic/brand names, dosage form(s), FDA approved indication(s), and major safety concerns.
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.
Pamela Mausner, MD
Brief Bio : Pamela Mausner, MD; Medical Writer/Editor and Healthcare Advocate; and Associate Editor, The Rx Consultant.