Adherence – Patients taking prescription drugs as directed by their doctor and counseled by other Health Care Providers; non-adherence is astonishingly high. Sometimes the term compliance is used interchangeably.
Adverse Drug Event (ADE) – Negative results (such as an allergic reaction or serious side effect) from taking a drug; can also result from the negative interaction of two or more drugs.
Boxed Warnings – Required to be prominent on the Package Insert (PI) by the Food and Drug Administration when potential negative effects of a drug are deemed serious enough.
Caregivers – Friends and family of patients who assist in providing and managing the patient’s health care, including prescriptions. Children of aging parents are a good example of the Caregiver population.
Compliance – Patients taking prescription drugs as directed by their doctor and counseled by other Health Care Providers; non-compliance is astonishingly high. Sometimes the term adherence is used interchangeably.
Consumer Medication Information (CMI) – Any information supplied to consumers about medication; includes pharmacy supplied information as well as Patient Package Inserts (PPIs) and Medication Guides.
Converters – Companies in the packaging industry that print and finish materials into final packages (such as folding cartons) and information delivery vehicles (such as PIs, PPIs and MedGuides) for manufacturers of drugs and other products.
Current Good Manufacturing Practices (cGMP) – Principles of controlled manufacturing practices (such as lot tracking, product separation, and line clearances) required by the FDA for pharmaceutical manufacturers and used by converters who supply printed literature to the pharmaceutical industry.
Med – Website containing FDA-approved Package Insert / Labeling Content.
Food and Drug Administration (FDA) – Department charged with regulating the safety and effectiveness of prescriptions drugs; also regulates food safety; part of the Department of Health and Human Services.
General Accountability Office (GAO) – An independent, non-partisan agency that works for Congress to provide objective analysis on key policy issues.
Health Care Providers – Professionals (doctors, pharmacists, nurses, others) who help patients deal with diseases and manage their health positively.
Institute of Medicine (IOM) – The health arm of the National Academy of Sciences, an independent, nonprofit organization that works outside of government to provide unbiased and authoritative advice to decision makers and the public.
Labeling Content (Package Insert or PI) – Printed information that accompanies prescription drugs containing “adequate directions for use and such adequate warnings” as required by the Food, Drug and Cosmetics Act of 1938.
Medication Guide (MedGuide) – An FDA-approved, manufacturer-supplied leaflet in a prescribed format aimed at patients that must accompany every prescription for certain drugs and classes of drugs based on the FDA’s assessment of the risks associated with that drug.
National Association of Boards of Pharmacy – An impartial professional organization that supports the 50 Boards of Pharmacy that regulate retail pharmacies in each state, with the goal of creating uniform regulations to support public health.
Package Insert (PI or Labeling Content) – Printed information that accompanies prescription drugs containing “adequate directions for use and such adequate warnings” as required by the Food, Drug and Cosmetics Act of 1938.
Patient Activation – In the Patient Involvement Model of Healthcare, refers to a patient’s knowledge, ability and willingness to manage his or her own health care.
Patient Engagement – In the Patient Involvement Model of Healthcare, adds proactive positive patient behavior (diet and exercise, e.g.) to Patient Activation.
Patient Involvement Model of Healthcare – A model based on the assumption that active patient involvement in their health care results in better health outcomes at lower costs; slowly supplanting a professional model that did NOT trust patients with information.
Patient Package Insert (PPI) – An FDA-approved, manufacturer-supplied leaflet in a prescribed format aimed at patients that must accompany every prescription for certain drugs using direct-to-consumer advertising or that carries a higher level of risk as assessed by the FDA.
Patients – Consumers of health care, including prescriptions drugs, doctor and hospital care, and in other settings that deliver care from professionals.
Pharmaceutical Manufacturers – Companies that manufacture drugs at sites approved by the FDA, utilizing Current Good Manufacturing Practices; FDA audits and approves their compliance with these principles at every manufacturing site.
Pharmaceutical Printed Literature Association – The PPLA is a trade group representing printers of regulated pharmaceutical information, including Package Inserts (PIs), Medication Guides (MedGuides), and Patient Package Inserts (PPIs) as well as other label packaging such as folding cartons and pressure-sensitive labels. Material, equipment, and technology suppliers are also part of the PPLA.
Pharmaceutical Research and Manufacturers Association (PhRMA) – An organization of the major pharmaceutical research companies, many of whom also manufacture existing and mature drugs.
Unified Agenda – Published in the fall and spring by the federal government, contains major regulatory initiatives and activities planned by all government departments.