Laws, Organizations, Etc.
The pharmacy world has many legal responsibilities. Over the years, laws have been enacted to increase the safety of medications and protect the well-being of the consumer. To help navigate these responsibilities, organizations and other references have been put into place.
Reference Books
For the exam, you will need to know different types of reference books. On the job, this information will be, most likely, electronically-accessed. Here are a few reference books that you need to know for the exam:
United States Pharmacopeia identifies drug standards.
Facts & Comparisons is a drug information reference.
Physician’s Desk Reference (PDR) has drug information; contains inserts from drug manufacturers.
The Red Book lists average wholesale pricing of prescriptions.
The Orange Book advises on therapeutic equivalencies of drugs.
Handbook of Over-the-Counter Drugs gives information on OTC drugs.
Handbook of Injectable Drugs gives information on IV solutions and drug-drug compatibility.
Organizations
Drug Enforcement Administration (DEA) is the United States federal law enforcement agency that oversees drug use.
Food and Drug Administration (FDA) is the United States federal agency that oversees, among other areas, the manufacture and safety of drugs. The FDA has a program called MedWatch to receive information about adverse events/reactions.
National Association of the Boards of Pharmacy (NABP) ensures uniform standards are established for state boards of pharmacy.
Amendments and Acts
Durham-Humphrey Amendment: prohibits non-OTC drugs to be dispensed with a prescription
Kefauver-Harris Amendment: requires all drugs manufactured in the United States to be pure, safe and effective for human use
Controlled Substances Act: requires pharmacies to keep records and establish security procedures for certainmedications
Food, Drug, and Cosmetic Act: requires drug companies to file a New Drug Application before a new drug can be introduced to market. Furthermore, it ensures a product cannot be mislabeled.
Pure Food and Drug Act: prevents manufacture, sale, and transport of adulterated, misbranded, or otherwise unsafe medications
Poison Prevention Packaging Act: sets the standards for child-resistant packaging
Occupational Safety and Health Act (OSHA): established to prevent workplace diseases and injuries
Prescription Drug Marketing Act: limiits sale or distribution of prescription drug samples to only those licensed to prescribe them
Combat Methamphetamine Act: requires that certain medication like pseudoephedrine be kept behind pharmacy counter in an effort to prevent the manufacture of methamphetamine. Pharmacies must document any sales of pseudoephedrine or other drugs listed in the act.
Health Insurance Portability and Accountability Act (HIPAA) protects confidentiality and security of health information
Drug Listing Act requires a National Drug Code (NDC) on the medication label to ensure the correct medication was chosen to be dispensed. This code is eleven digits long:
Federal Hazardous Substance Act ensures proper disposal of hazardous material. Example: needles used to give a flu shots are placed in an approved container.
Orphan Drug Act incentivizes drug manufacturers to develop and market medications that will treat uncommon diseases.