Implications of Recent Controlled Substance Policy Initiatives

Recent legislative and regulatory activity designed to address controlled substance diversion and overuse of narcotics is having a significant impact on prescription drug utilization and patient care in the United States. Although providers and patients are the focus of these new requirements, the designers and implementers of formularies and medication use protocols need to be aware of salient features of these initiatives. Formulary drug product selection, prior authorization procedures and drug utilization strategies should be reconsidered in accordance with the changes in controlled substance oversight. The primary focus of this article involves recent approaches to controlling the illegal acquisition of licit prescriptions, particularly opioid pain relievers (OPR). According to the Centers for Disease Control and Prevention (CDC), in 2008 OPRs were involved in 74% of the 20,000 fatal prescription drug overdoses in the United States. This represents an increase of over 300% since 1999 and these fatalities now exceed death by cocaine and heroin combined. [Interestingly, the death rate varied five-fold by state, largely reflecting different levels of opioid regulation and oversight. They also noted that sales of OPRs quadrupled between 2000 and 2010 and that OPR abuse cost health insurers over $72 billion annually in healthcare costs

Professional roles evolve with changing landscape of legal risk

Opioid-use monitoring, medication-error prevention, and counseling/duty-to-warn issues illustrate new or emerging legal risks for pharmacists as their roles expand

Regulatory and legislative disparities with cannabis present challenges to P&T committees and health care providers

Ms. Marcoux is a Clinical Professor of Regulations and Managed Care and Director of Pharmacy Outreach Programs at the University of Rhode Island College of Pharmacy in Kingston, Rhode Island. Dr. Holmes is a Post-Doctoral Fellow at Rutgers University’s HOPE Center in Piscataway, New Jersey. Dr. Vogenberg is Principal, Institute for Integrated Healthcare in Greenville, South Carolina, and Adjunct Assistant Professor, Pharmacy Administration, Department of Health Economics Research at the University of Illinois College of Pharmacy in Chicago, Illinois

Telehealth: Applications from a legal and regulatory perspective

Telehealth is becoming mainstream in the U.S., as more consumers, employers, hospital systems, and even insurers adopt the technology. The authors explore the challenges of regulation, reimbursement, and licensing as the modality evolves