Intro to Pharmacology
Drug Name
Chemical name - describes the molecular structure of the drug Generic - official name Brand or trademark - legal, proprietary name of the drug given by the company Drug class or therapeutic Class - usually describes the action of the drug
Over the counter drugs & dietary supplements
Considered "drugs" that have been found to be safe and appropriate for use without the supervision of a heath care professional Do not require a prescription
How to increase adherence
Develop a patient friendly environment so patients feel safe to tell you when they deviate from your prescribed treatment Incorporate a medication adherence assessment tool into your practice Have a high degree of awareness for non-adherence Assess adherence
Dietary Supplements
FDA Definition "a product intended for ingestion that contains a "dietary ingredient" intended to add further nutritional value to (supplement) the diet. It may be one or any combination, of the following substances: vitamin, mineral, herb or botanical." Fall under category of food Not required to test new ingredients or supplements in clinical trails Required to comply with current GMP (good manufacturing practices) Dietary or nutritional supplements cannot make "drug claims" Must be properly labeled
What is a drug?
FDA Definition: A drug is defined as: A substance recognized by an official pharmacopoeia or formulary. A substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. A substance (other than food) intended to affect the structure or any function of the body."
Medwatch
FDA safety information and adverse reporting program A portal for healthcare professional or consumers to report observed or suspected adverse events from drugs, etc. It is voluntary
Food, Drug, and Cosmetic Act of 1938
Required safety studies for new drugs Manufacturers could not make false claims FDA could inspect factories Control extended to cosmetics and devices Requires safe tolerances for unavoidable poisonous substances
Drug Price Competition and Patent Restoration Act of 1984
Requires bioequivalence for generic drugs
Kefauver-Harris Amendments (1962) to the FDC Act
Requires proof of efficacy and safety for all new agents & all drugs already on the market since 1938 Process to report adverse events due to drugs to the FDA established Required informed consent for clinical studies Drug ads must disclose side effects FDA issued "Good Manufacturing Practice" rules for manufacturing, packing, or holding of finished pharmaceuticals
Dietary supplement health and education act of 1994
Requires specific ingredient and nutritional information for dietary supplements Established standards for dietary supplements Prohibited full FDA review of supplements and botanicals as drugs Allowed unregulated advertising
Adverse Drug Reaction (ADR)
an unexpected harm arising from a justified action where the correct process was followed for the context in which the event occurred. Adverse event occurs in an incident in which a patient is harmed.
Early non-persistence of first-fills
failure to refill prescription within six months
Secondary nonadherence to medications
defined as filling a prescription but not taking the medication as prescribed.
Primary nonadherence to medications
defined as never filling a prescription.
Steps in using medication:
1. Prescribing; choose appropriate medication, communicating the details of the plan and documentation 2. Administering; check for allergies, prepare the medication, and giving the right medication to the right patient, in the right dose by the right route, at the right time 3. Monitoring; observing the patient subjectively and objecting measuring physical signs to ensure that the drug is working as intended. & documentation.
Risk Factors for medication nonadherence
Age Ethnicity Health beliefs and medication taking behavior Depression Previous experience with medications Number of medications Forgetfulness Financial Factors
1953-1962 Thalidomide Tragedy
Gave pregnant woman thalidomide to help with sickness associated with pregnancy. Unfortunately, fetus developed deformities in their limbs
Durham-Humphrey Act of 1952
Gave the FDA the power to determine which products could be sold without prescription
What is health literacy
Health literacy is the degree to which individuals have the capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions.
FDA Amendments Act of 2007
Increased authority of FDA over drug marketing, labeling, and consumer direct advertising. Required post-marketing studies; known serious risk, signals of a serious risk, or identify unexpected serious risk
Health literacy affects people's ability to:
Navigate the healthcare system including filling out complex forms and location providers Sharing personal information such as health history Engage in self-care and chronic-disease management Understand mathematical concepts such as probability and risk
Key elements of plain language include
Organizing information so that the most important points come first. Breaking complex information into understandable chunks Using simple language and defining technical terms Using the active voice
Drug released on the market
Phase 4: post-marketing studies The FDA continues to monitor drugs after they are released on the market The FDA may demand certain trails be conducted to asses or monitor for adverse events when the drug is used in the population at large
Who is at risk for low health literacy
Populations most likely to experience low health literacy are older adults, racial and ethnic minorities, people with less than a high school degree or GED certificate, people with low income levels, non-native speakers of English, and people with compromised health status.7 Education, language, culture, access to resources, and age are all factors that affect a person's health literacy skills.
Drug Development Process
Pre-clinical Phase Step 1: usually takes place in pharmaceutical industry lab. Discovery step: Hundreds to thousand of compounds may be tested. Development step: experiments are done to understand compound activity. Step 2: Compounds are evaluated in animals to determine acute and short term toxicity. Clinical Phases Phase 1: small number of healthy volunteers, open studies, determine the pharmacokinetics of a drug, is it safe?, dose? Phase 2: Larger number of patients who have the disease, proof of concept stage, dose response curve determined, highest rate of drug failure is in this stage, 25% of drugs move to next phase. Phase 3: larger number of patients with disease being tested, test safety and efficacy, studies usually double blinded or crossover in design, New Drug Application (NDA) is submitted, FDA reviews NDA, if approved, drug can be on market.
Prescription Drugs
Prescribed by a doctor or licensed healthcare provider with authority to prescribe Dispensed & purchased at or through a pharmacy Prescribed for & intended to be used by one person Regulated by FDA through the NDA process
How can errors occur when using medications?
Prescribing; inadequate knowledge, not considering specific patient factors, wrong patient, wrong drug, etc, calculation errors, inadequate communication & documentation Administration; wrong patient, wrong drug, etc, failure to administer, inadequate documentation Monitoring; lack of monitoring for adverse events, labs, vital signs, lack of determining if therapeutic goals have been met, lack of documentation, lack of communication
What is the FDA?
The FDA, US Food and Drug Administration, is an agency within the US Department of Health and Human services. Became a federal protection agency in 1906 with the passage of the Pure Food and Drugs Act. FDA is responsible for protecting the public heath by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nations food supply, cosmetics, tobacco products, and products that emit radiation.
Health literacy is dependent on individuals and systemic factors:
communication skills of lay persons and professionals Lay and professional knowledge of health topics culture Demands of the healthcare and public health systems Demands of the situation/context
Remember the 5Rs
right patient right drug right route right dose right time
Plain Language
strategy for making written and oral information easier to understand. It is one important tool for improving health literacy. Plain language is communication that users can understand the first time they read or hear it. With reasonable time and effort, a plain language document is one in which people can find what they need, understand what they find, and act appropriately on that understanding.
Medication adherence
the extent to which patients take medication as prescribed by their healthcare providers.
