PharmPrac7e-Chapter3-WLpresentation

[Audio] Welcome to the Pharmacy Practice for Technicians Seventh Edition presentation..

[Audio] Chapter Three: Drug and Supplement Development.

[Audio] At the end of this chapter, you will be able to: Discuss and differentiate between the different classifications of drugs. List the essential components of a prescription. Identify advances in science and pharmacology and the impact they had on society ..

[Audio] Section three point one: what is a drug?.

[Audio] Because new drug developments are built upon the scientific framework provided by earlier groundbreaking discoveries, it is important to know a little about the history of key discoveries to understand their effects on pharmacy practice today. Many people think of drugs as only those substances manufactured by a pharmaceutical drug company for their medicinal effects, or narcotics that can be easily abused. However, all drugs fall into one of three broad categories as designated by the FDA. The first is Prescription Drugs. Formerly known as a legend drug, prescription drugs can only be legally dispensed to a patient only upon the receipt of a state licensed healthcare provider's directive. This is generally in the form of an e-prescription sent online to the pharmacy directly from the prescriber, or a handwritten, faxed, or authorized verbal prescription. Prescription must include the prescriber's name, address, phone number, date written, and signature to be considered legal. A 10-digit National Provider Identifier (NPI) is often included for insurance purposes and prescriptions for controlled substances require the prescriber's DEA number. Finally, a valid prescription must have the patient's name, address, and date of birth, and the drug's name, dosage, duration, and prescribing date..

[Audio] The second category is over-the-counter, or O-T-C drugs. These are medications that may be sold without a prescription. Common examples include aspirin, acetaminophen, and ibuprofen. The third category is anything considered a homeopathic remedy. Homepathic products are made of natural substances and are purported to boost the immune system. Vitamins, minerals, herbs, and protein, energy, and nutritional drinks are not considered drugs by the FDA but rather dietary supplements..

[Audio] Section three point two: Classifications for Drugs.

[Audio] Because medications serve a variety of purposes in a patient's healthcare regimen, pharmacy technicians must be knowledgeable about the intended functions of commonly used medications; this knowledge can help them to recognize when something seems amiss in a prescription order. Medications fall into one of five classifications: A therapeutic agent is a medication that targets a specific need in the body. They can maintain health, relieve symptoms, combat illness, and reverse disease processes. A prophylactic agent prevents illness or disease from occurring. Vaccines that prevent disease, like Dr. Salk's polio vaccine, are considered prophylactic agents. A destructive agent works to kill specific living elements, such as bacteria, fungi, viruses, or abnormal cancer cells. Different antineoplastic drugs are used in combination to slow the growth of cancer cells at different phases of their cell growth cycles. A pharmacodynamic agent is a medication that alters body functioning in a desired way. For example, caffeine is considered a pharmacodynamic agent because it stimulates the nervous system. A diagnostic agent is a substance that helps healthcare providers diagnose a medical condition. These can be dyes or chemicals containing radioactive elements that are used to help healthcare professionals visualize or track the state or actions of cells, organs, and systems..

[Audio] A pharmacodynamic agent is a medication that alters body functioning in a desired way. For example, caffeine is considered a pharmacodynamic agent because it stimulates the nervous system. A diagnostic agent is a substance that helps healthcare providers diagnose a medical condition. These can be dyes or chemicals containing radioactive elements that are used to help healthcare professionals visualize or track the state or actions of cells, organs, and systems..

[Audio] Section three point three: Major Scientific Discoveries in Medicine and Drug Therapies.

[Audio] The varied uses of medications arose out of scientific discoveries in the related fields of medicine and pharmacy. In the late 1700s, scientists were just beginning to understand the existence of microorganisms—microscopic or one-celled organisms—and their role in causing illness. An understanding of the role of microbes in causing illness developed into the germ theory of disease. Groundbreaking discoveries in germ theory led the way to vaccines, antibiotics, and the aseptic techniques used today. A major cause of premature deaths globally in the 1700s was a disease called smallpox. Dr. Edward Jenner observed that dairy workers previously exposed to cows with cowpox didn't get smallpox. Jenner theorized that cowpox exposure triggered people's bodies to provide special protection, or immunity, to the smallpox virus. Jenner called the inoculation procedure a vaccination, from the Latin word vaccinus, meaning "from cows," leading to the term vaccine..

[Audio] Section three point four: Drug Ingredients and Sources.

[Audio] Within a wide range of complex drugs and supplements, there is also a wide range of ingredients. Some are key therapeutic ingredients, and others support the actions, stability, or administration of the key ingredients. Most medications contain one or more active ingredients as well as several inactive or inert supporting ingredients. The active ingredients are the biochemically active components that exert the desired effects—for example, eradicating bacteria or viruses, lowering blood pressure or cholesterol, or controlling heart rates. An inert ingredient has little or no physiological effect. Common inert ingredients include those that are needed to stabilize the tablet, capsule, or liquid formulation; those that provide the raw material for many topical creams and ointments; those that ensure sterility of injectable products; or those masking the unpleasant taste of some unpleasant oral medications for pediatric patients..

[Audio] Drug ingredients are derived from various sources and can be classified as natural, synthetic, synthesized, semisynthetic, and biologically engineered. Many drugs are derived from naturally occurring biological products, such as single-celled organisms, plants, animals and humans, or minerals. For example, armour Thyroid, a medication for poorly functioning thyroids, is an extract from desiccated (dried) pig thyroids. There are four basic classifications for drugs that are created in a laboratory setting: A synthetic drug is a drug that has been created in the laboratory from a series of chemical reactions to produce a specific pharmacological effect. Synthesized drugs are developed to mimic the pharmacological action of the naturally occurring sources. Semisynthetic drugs are natural substances combined with laboratory substances designed to (1) improve the efficacy of the natural product; (2) reduce its side effects; (3) overcome medicinal obstacles; or (4) broaden the scope of its uses. And Biogenetically engineered drugs are derived from the use of biotechnology to produce unique drugs with specific therapeutic effects..

[Audio] Section three point five: The Prescription Drug Approval Process.

[Audio] A pharmaceutical company must do extensive preclinical laboratory research on animals before an investigational new drug (IND) application can be officially initiated with the FDA. In its application, the developer must offer a compelling case for the human need for the drug, the results of the animal studies, an explanation of how the drug would be manufactured, and a detailed description of the proposed clinical studies on humans..

[Audio] The Kefauver-Harris Amendments of 1962 were passed in response to the birth of thousands of infants—mostly in Europe—with severe abnormalities resulting from mothers who had taken a new tranquilizer called thalidomide while they were pregnant..

[Audio] Section three point six: Nonprescription Drug Approval Process.

[Audio] Since nonprescription medications and supplements are not considered as potent, potentially dangerous, or addictive as prescription drugs, the FDA does not require as intensive an approval process for them. To get approval to bring an OTC drug to market, the manufacturer has to submit a new drug application with a specific dose and indication. The FDA must check to see that the drug is safe and effective for use when the labeled directions on the container are followed with regard to dose, frequency, precautions and contraindications, and duration of therapy..

[Audio] It is important for OTC drugs to have adequate product labeling, written in easily understood terms, as patients may have no contact with a pharmacist or typed physician instructions. The FDA-required labels contain a prominent "Drug Facts" box that lists the active ingredients, purposes, and uses of the product, along with any warnings and directions, including age-appropriate dosing..

[Audio] Section three point seven: National Drug Code Number.

[Audio] Once a brand name or generic drug receives FDA approval, it is assigned a unique National Drug Code (NDC) number that appears on all drug stock labels as well as on the prescription labels. The NDC is a 10- to 11-character NDC number made up of the following parts: · a four- or five-digit labeler code, identifying the manufacturer or distributor of the drug · a three- or four-digit product code, identifying the drug · a one- or two-digit package code, identifying the packaging size and type.

[Audio] Pharmacists and technicians use the NDC number to check that the correct drug is entered into the computer and dispensed. The pharmacy technician then focuses on the product and package code for filling the prescription, insurance reimbursement, and inventory control..

[Audio] Section three point eight: FDA Medication Safety Surveillance.

[Audio] Although every medication goes through a rigorous approval process, consumers should keep in mind that all drugs—prescription, OTC, and all dietary supplements—have a risk of toxicity. In recognition of this fact, the FDA continues to gather information about any serious adverse reactions from approved medications. An adverse drug reaction (ADR) is defined as a negative consequence to a patient from taking a particular drug. Even after many years of research and clinical studies, some medications that enter the marketplace will still place individual patients at risk for a serious adverse reaction—an event that may not always be preventable or predictable..

[Audio] The FDA established a nationwide surveillance system to serve as a conduit for reporting serious effects of certain medications. This Adverse Event Reporting System (AERS) is a centralized database that gathers and stores information from two separate programs: MedWatch for drugs and Vaccine Adverse Event Reporting System (VAERS) for vaccines. The FDA uses the collected information (with privacy protected) to track problems or issues that were not apparent when the medications and vaccinations were in clinical trials..

[Audio] This concludes the Pharmacy Practice for Technicians Seventh Edition presentation for Chapter Three..