Access to Hepatitis C Cures for Medicaid Patients
For most of history, hepatitis C has been incurable after the development of chronic infection.
Multimodal Analgesia: Acute Pain Relief for the Whole Patient
In the last few decades, rising concerns about the misuse and abuse of opioids have brought pain and pain management to the forefront as a public health concern. In response, the National Institutes of Health and the Institute of Medicine released in 2015 the first-ever National Pain Strategy, calling on healthcare providers to customize pain […]
Medication for Long-Term Care Residents: Reducing Overuse Without Compromising Access and Care
By David Charles, MD and Mary Ann Chapman, PhD More than 2 million elderly Americans live in long-term care settings such as nursing homes. Residents of these facilities take an average of nine different medications each day, with the most common being medications for digestive problems, psychological symptoms, and pain. In 2011, 24% of residents in […]
Improving Patient Access to Immuno-Oncology Therapies
By Alan Marks, MD, and Mary Ann Chapman, PhD Despite major advances in cancer medicine (oncology), cancer remains a deadly disease, accounting for nearly 600,000 deaths in the US annually. For many years, the primary treatments for cancer have been surgery, chemotherapy, and radiation therapy. Over the past decade, medications have been developed that act directly […]
Unresolved Policy Issues Impact Patient Access to Biosimilars
By David Charles, MD and Mary Ann Chapman, PhD More than five years have passed since Congress approved an abbreviated regulatory pathway for biosimilars under the Biologic Price Competition and Innovation Act as part of the Patient Protection and Affordable Care Act. Biosimilars are biological medications deemed highly similar, but not identical to, those already […]
Informed Prescribing: Physicians Need Complete and Specific Prescribing Information for Biosimilar Medications
By David Charles, MD and Mary Ann Chapman, PhD Every prescription medication approved in the United States is accompanied by a printed document for physicians called the prescribing information. The prescribing information is also known as the package insert or product label—not to be confused with the box or paper affixed to a medication bottle […]
Access to Integrated Care for Chronic Pain
Approximately one in five Americans suffers from chronic pain, with more than 60% of these reporting that their pain is constantly present. Although many therapies are available for chronic pain, up to two-thirds of patients are inadequately treated. Read the Paper
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 […]
