2012: New drug approvals for the pharmacist
Pharmacists in community-based practice.
Universal program number: 0401-0000-13-002-H01-P
Activity type: Knowledge-based
To improve the pharmacist's ability to provide consultation on new therapeutic agents approved for use in 2012, as well as their place in therapy.
The Food and Drug Administration has approved more than 500 drugs in the past decade.1 In 2012, the FDA approved 39 drugs.2 The FDA has been working on improvements to their processes and has made great strides accelerating the development and availability of drugs. The FDA improved the review and approval of new drugs by utilizing "expedited approval" pathways and by streamlining clinical trial requirements to permit small, shorter or fewer studies wherever possible.2 Most of the 35 approvals of novel drugs in 2012 were approved after a single review cycle and before their approval anywhere else in the world. The FDA also stuck to the target dates for approving drugs under the Prescription Drug User Fee Act. The FDA has built its ability to monitor drug safety and quickly detect and address drug risks that emerge after a drug is marketed, mainly through the FDA MedWatch program. MedWatch, the FDA safety information and adverse event reporting system, provides pharmacists and other healthcare providers with up-to-date information on drug safety after the approval process. Pharmacists can quickly register through the FDA website (FDA.gov/Safety/MedWatch) to receive email or text messages of such alerts.3 This review will highlight the new drugs approved in 2012 with a focus on efficacy highlights from clinical trials, important monitoring and side effects.
Upon completion of this program, the pharmacist should be able to:
- Identify the new therapeutic agents approved for use in 2012.
- Describe the newly approved agents' indications and practical considerations regarding their use in a community setting.
- Compare the new agents to the drugs already available and discuss their place in therapy.
- List counseling points to convey to patients regarding new drugs.
To obtain credit:
A minimum test score of 70% is needed to obtain credit. Submit your answers to the learning assessment questions online at DrugStoreNewsCE.com. Your statement of credit will be available through CPE Monitor located at NABP.net. To ensure transmission of credit hours to CPE Monitor, you must enter your correct e-PID number in your CE profile.
All customer service questions should be directed to (800) 933-9666.
If you are a paid enrollee, there is no cost to participate in this lesson. The fee for participants who are not enrolled is $13.95.
Drug Store News is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. This CPE Activity is approved for pharmacists and is worth 2.0 contact hours (0.2 CEUs). The activity is available for CE credit through February 1, 2016.
By CoraLynn B. Trewet, MS, PharmD, BCPS, CDE, associate professor (clinical), University of Iowa
CoraLynn B. Trewet and DSN editorial and continuing education staff do not have any actual or potential conflicts of interest in relation to this lesson.
- 2.00 Pharmacist