Pharmacy Practice, Compliance, Risk Management and Controlled Substances Act
Barton Klugman & Oetting LLP’s Pharmacy Practice, Compliance and Risk Management Practice Area has recognized expertise in leading company compliance efforts: reviewing and evaluating medication practices against changing regulations, developing corrective action, and enhancing patient safety and reducing the risk of external government agency involvement. Additional expertise lies in drug product liability, including failure to warn; pharmacy/ pharmacist standard of care; drug utilization review; pharmacist’s duty of consultation on drug therapy, compliance, side effects, adverse effects, drug-drug interactions; and drug-disease state interactions; evolution of and current laws related to controlled substances; substance abuse and misuse; prescription drug abuse; opioids.
Areas of expertise include:
- Pharmacy/Pharmacist Standard Of Care, Avoidance of Malpractice
- Medication Safety and Quality Improvement; Pharmacy Policy and Procedures
- Pharmacy Management, Regulatory Compliance and Risk Management (Board of Pharmacy); Drug Enforcement Administration (DEA); Controlled Substances Act; Food, Drug, and Cosmetic Act; etc.)
- Controlled Substances Act: Red Flags, Corresponding Responsibility; In the Matter of the Accusation Against Pacifica Pharmacy and Thang Tran (2013); Sternberg v. California State Board of Pharmacy (2015).
- Substances of Abuse, Misuse, and Addiction (drug abuse. licit and illicit substances)
- Drug product liability (including failure to warn, side effects, adverse effects, drug interactions and pharmacology)
- Forensic consultation and expert witness testimony
- Assist inventors of pharmaceutical devises and formulations and bring them to the market