Abuse-Deterrent Opioid Formulations: Promising Technology, Unique Challenges
Prescription pain medications such as opioids offer important treatment options for people with severe pain, often providing relief and allowing some to resume their daily activities. Unfortunately, these drugs can be misused, abused, or diverted to others for illicit use—problems that have become pervasive across the country. Each year approximately 4.5 million Americans use prescription […]
What is Indication Extrapolation and Should it be Allowed with Biological Medications?
By David Charles, M.D. and Mary Ann Chapman, Ph.D. If a prescription medication is approved for the treatment of a specific disease or condition, do you assume that it has undergone full testing for that condition? Tis assumption is usually valid: New medications approved in the United States must undergo extensive testing for the conditions […]
Ensure Patient Safety When Naming Biological Medications
By David Charles, MD and Mary Ann Chapman, PhD If requiring biological medications to have unique names would help ensure patient safety, wouldn’t it be an important convention to implement? The United States Food and Drug Administration (FDA) and several other organizations are currently considering requirements for naming biological medications—those often produced from cells or […]
The True Costs of Health Plan Specialty Tiers
By David Charles, MD and Mary Ann Chapman, PhD An important but rarely asked question is whether it costs more to fill prescriptions for needed medications than to fail to fill these prescriptions. Last year the Congressional Budget Office (CBO) released a memo entitled Offsetting Effects of Prescription Drug Use on Medicare’s Spending for Medical […]
