2.2 Types of Oversight

To understand how these various oversight bodies function, one needs to recognize the different levels of legal and nonlegal influences, and how they work together.

Laws

A law, also known as a statutory law, is an overall rule that is passed by the legislative branches of federal, state, and local governments to guide conduct. Combined, the multilevel system of laws establishes the minimum acceptable standards to protect the public.

Regulations

Regulations are a set of written rules and procedures that exist to carry out a law. For example, the FDA, a federal governmental agency, has published regulations on the drug approval process, generic drug substitution, patient counseling, and adverse reaction reporting systems. A violation of any FDA regulation is a breaking of federal law. Another national government agency, the Drug Enforcement Administration (DEA), has rules regulating the distribution, storage, documentation, and filling of prescriptions for controlled substances or legally restricted drugs. The federal programs of Medicare and Medicaid have regulations as well that are put in place for pharmacists and pharmacy technicians who dispense and bill prescriptions for older adults and low-income and disabled patients.

Within each state, the board of pharmacy oversees additional pharmacy rules that must be followed within its borders. As discussed in Chapter 1, licensure, registration, and certification requirements for pharmacy technicians vary from state to state. When there is a conflict between a state and a federal law or regulation, the more stringent law or regulation always applies.

Standards

A standard is a a guideline, benchmark, or desired level of quality to serve as the expected norm for a product or professional performance. Standards exist for drug products, individual professional conduct, and both community and institutional pharmacies—including hospitals, HMOs, nursing homes, and mail-order warehouses. For example, the US Pharmacopeial Convention (USP)—a nongovernmental professional organization—works with scientists to set ingredient and manufacturing standards that must be met by pharmaceutical companies before their new drug products can be submitted to the FDA. The USP also sets national standards for pharmacies preparing sterile and nonsterile preparations.

Ethics

Whereas laws and the resulting regulations represent the minimum level of legal oversight to protect the public, and professional standards represent quality in practice, professional ethics encompasses the higher realm of ideals, values, and missions that are held by professions and individual practitioners. Pharmacists and technicians are encouraged to abide by the oaths and the code of ethics set out by their professional organizations to achieve the highest standards of practice and care for patients as opposed to the minimum. This united professional goal to seek the best outcomes for patients helps hold healthcare professionals accountable for their decisions and actions in the workplace. It helps patients trust in the pharmacy profession as a whole as well as trust in individual pharmacists and pharmacy technicians. If a legal challenge is made related to an individual’s professional actions or choices, they are compared with the accepted practices of other professionals in the field.

Hospitals and other healthcare companies generally establish mission statements and ethical codes of conduct for the facilities and their employees too. Following these established codes of ethics in one’s personal and workday actions is an essential part of professionalism, which will be covered in greater detail in Chapter 15.