PTCB - Chapter 3 - Drug Regulation and Control - Key Concepts

Drug Regulation

• In the US, the leading federal enforcement agency for regulations concerning drug products is the Food and Drug Administration
• The distribution of drugs that may be easily abused is controlled by the Drug Enforcement Administration (DEA) within the Justice Department
• Manufacturers' containers for prescription drugs must have this legend on the label: "Rx only"

New Drug Approval

• Before it is approved for marketing, a new drug must be shown to be both safe and effective and that its benefits substantially outweigh its risks
• Placebos are inactive substances used to test the effectiveness of drugs

Marketed Drugs

• Once a patient fir a brand drug expires, other manufacturers may copy the drug and release it under its generic name

Behind the Counter OTC Medications

• Some OTC medications are kept behind the counter even if they do not require a prescription; these include OTC medications containing ephedrine and pseudoephedrine, exempt narcotics, and emergency contraceptives

Sample Labels

• The minimum requirements on prescription labels for most drugs are as follows: name and address of dispenser, prescription serial number, date of prescription or filling, name of prescriber, name of patient, directions for use, and cautionary statements

Controlled Substances

• Manufacturers must clearly label controlled drugs with their control classification
• All prescribers of controlled substances must be registered with the DEA and are assigned a DEA number that must be used on all controlled drug prescriptions

Additional DEA Forms

• Although DEA Form 222 is the most frequently used DEA form, manufacturers, distributors, and dispensers of controlled substances are also required to use other specific DEA forms to register with the DEA and otherwise monitor inventory

Public Safety

• Recalls are, with a few exceptions, voluntary on the part of the manufacturer

Law and the Technician

• Federal laws provide a foundation for the state laws that govern pharmacy practice
• State boards of pharmacy are responsible for licensing all prescribers and dispensers and administering regulations for the practice of pharmacy in the state
• Legal liability means you can be prosecuted for misconduct, including negligence

Ethics and Compliance

• Taking on ethical perspective means examining a situation with moral standards
• Institutions form committees such as institutional review boards to provide guidance on ethical issues and ensure compliance