New Algorithm Surveys Alterations in DNA and Millions of Points in the Human Genome
First Oral Drug Increases Activity of the Body’s Deficient Enzyme
Venous Thromboembolism and Other Risks to Be Evaluated in Postmarketing Studies
Researchers Recommend Increased Testing for Men
New Draft Guidance Seeks to Better Target Patient Needs
It’s All in How the Data Are Analyzed
Two Phase 3 Studies Met Endpoint of Complete Clearance of Lesions
Radiation Exposure Remains a Risk

P&T August 2018
Table of Contents


Randomized controlled trials have long been the gold standard for evidence in medical product evaluation, but there is growing support for the use of real-world evidence (RWE). The authors review the benefits and limitations of RWE and discuss the implications for P&T committees.
Incomplete or inaccurate drug-allergy histories can be detrimental to patient safety and lead to medication errors. The authors conducted a quality-improvement project and developed a standardized drug allergy questionnaire that can be adapted by institutions and targeted to patients at higher risk of having inaccurate allergy histories.
Several studies in recent years suggest that drug appearance may be an important factor in medication non-adherence. The authors characterized the range of appearances and costs of 16 oral solid generic medications in four chronic disease/drug-management conditions: hypertension, diabetes, heart failure, and hypercholesterolemia.
Pipeline Plus
Poor patient adherence is fueling keen interest in the development of drugs for glaucoma management. Several long-acting formulations of existing medications are in the early stages of development, as are new therapeutic classes such as guanylate cyclase activators.
Meeting Highlights
We review key findings in the areas of prostate cancer, non–small-cell lung cancer, breast cancer, esophageal cancer, pancreatic cancer, leukemias, metastatic colon cancer, and one session on molecular profiling guidance of therapy.


Medication Errors
Managing home infusion patients in the hospital and emergency department
Prescription: Washington
FDA guidance on outsourcing facilities and 503A pharmacies
Approvals, new indications, regulatory activities, and more
Lofexidine hydrocholoride (Lucemyra) for opioid withdrawal; erenumab-aooe (Aimovig) for migraine; and sodium zirconium cyclosilicate (Lokelma) for hyperkalemia