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a form of alternative medicine in which thin needles are inserted into the body. It is a key component of traditional Chinese medicine

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acupuncture

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including hormones, vaccines and serums, which are naturally produced in animal cells (including human), or are produced in microorganisms

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Biologics

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Terrorism involving the intentional release or dissemination of biological agents

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Bioterrorism

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named after the black label appearing around drug safety information on package inserts, eventually became one of the primary alerts for identifying extreme adverse drug reactions discovered during and after review. (Page 6).

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black-box warning

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complementary and alternative medicine (CAM) Examples of CAM:

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~dietary supplements, vitamins , minerals ,herbs , extracts from natural substances , amino acids , fibers such as psyllium and guargum ~biofeedback ~homeopathy ~chiropractic ~massage therapy ~hypnotherapy ~traditional Chinese medicine naturopathy, acupuncture and acupressure , yoga, Tai Chi, Pilates

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An experiment or clinical trial in which the researchers but not the subjects know which subjects are receiving the active medication or treatment and which are not: a technique for eliminating subjective bias, as the placebo effect, from the test results

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single blind study

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in which neither participants nor the experimenters know who is receiving a particular treatment. Useful for preventing bias due to demand characteristics or the placebo effect.

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double blind study

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Removes a prescription or over-the-counter drug from the market

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drug recall

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The first comprehensive listing of U.S. drug standards published in 1820 Because few drugs are compounded now, the definition of ____ has changed to also mean, ~list of drugs stocked in a hospital's pharmacy, or, ~a list of drugs that an insurance company will allow (i.e., pay for) for its covered policy-holders

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formulary

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Natural alternatives including extracts, minerals, vitamins and dietary supplements. If these are derived from plants they are known as herbal medicines.

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herbal medicine

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The treatment of disease by minute doses of natural substances that in a healthy person would produce symptoms of disease

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Homeopathy

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toxic levels of vitamins, (Page 499)

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hypervitaminosis

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Healing-oriented medicine that takes account of the whole person (body, mind, and spirit), including all aspects of lifestyle. It emphasizes the therapeutic relationship and makes use of all appropriate therapies, both conventional and alternative.

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integrative medicine or integrative health

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A system of alternative medicine based on the theory that diseases can be successfully treated or prevented without the use of drugs, by techniques such as control of diet, exercise, and massage.

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Naturopathy

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Non certified therapies based on naturaly foun substances (probably)

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natural alternative therapies

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When a drug is being prescribed for a condition for which it is not FDA-approved, (Page 9).

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off-label use

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Name the five categories of professionals who may be licensed to prescribe drugs in Texas.

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physicians, dentists, veterinarians, and with certain stipulations, nurse practitioners and physician's assistants.

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For the first time in U.S. history, this legislation mandated evaluation of the safety of drugs, cosmetics and therapeutic devices before the products could be marketed (sold) to the public.

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The Food, Drug and Cosmetic Act of 1938

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drug companies must prove that their drugs are effective as well as safe. drug companies must disclose accurate information regarding side effects of the drugs they produce and sale.

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The Kefauver-Harris Amendment of 1962

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it enhanced controls on biologic agents and toxins, and mandates requirements intended to protect the U.S. food, water and drug supplies

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The Bioterrorism Act of 2001

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gave the federal government control over the production of vaccines, serums and other blood products. Today, that list also includes agents such as allergenics and gene therapy products.

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Biologics Control Act of 1902 1

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established the Center for Biologics Evaluation and Research (CBER), which is now a division of the Food and Drug Administration

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Biologics Control Act of 1902 2

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Defined adulterated foods as those with the following additives: a. reduced quality fillers b. coloring to conceal a damaged or inferior product c. "filthy, decomposed, or putrid" substances

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Pure Food and Drug Act of 1906 1

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Banned interstate commerce of adulterated foods unless clearly labeled as such

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Pure Food and Drug Act of 1906 2

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Provided for federal inspection of meat products

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Pure Food and Drug Act of 1906 3

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a far less restrictive law that regulates herbal products and specialty supplements

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Dietary Supplement Health and Education Act of 1994 1

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Dietary supplements do not have to be tested by the manufacturer prior to marketing.

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Dietary Supplement Health and Education Act of 1994 2

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The effectiveness of a dietary supplement does not have to be demonstrated by the manufacturer.

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Dietary Supplement Health and Education Act of 1994 3

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The manufacturer does not have to prove the safety of the dietary supplement. It is the government's job to prove that the dietary supplement is unsafe and to take the necessary steps to remove it from the market.

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Dietary Supplement Health and Education Act of 1994 4

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The label of a dietary supplement must clearly state that the product is not intended to diagnose, treat, cure, or prevent any disease. However, claims about a product's effect on body structure and function are allowed, including the following: ■ Helps promote healthy immune systems ■ Reduces anxiety and stress ■ Helps to maintain cardiovascular function ■ May reduce pain and inflammation

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Dietary Supplement Health and Education Act of 1994 5

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Pre-clinical evaluation 1. Includes basic scientific research on cultures or animals .... NOT on humans 2. Current regulations mandate the pharmaceutical company must demonstrate evidence of relative safety and probable efficacious therapeutic action before human testing is permitted. 3. If the drug meets the requirement stated above, the drug company must submit an Investigational New Drug Application (INDA). The FDA must approve this application in order for the drug to be shipped across state lines for clinical trials.

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Stage I drug approval process

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The four-stage process of testing and approval of new drugs.

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Stage I: Pre-clinical evaluation Stage II: Clinical Evaluation (Clinical Trials) Stage III: Submission of New Drug Application (NDA) Stage IV: Postmarketing Surveillance

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Clinical Evaluation (Clinical Trials)

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Stage II drug approval process

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Submission of New Drug Application (NDA)

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Stage III drug approval process

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Postmarketing Surveillance

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Stage IV drug approval process

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i. The drug is given to a limited number of human volunteers ii. Focus: to study the effects of the drug in broad ranges of dosages

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Stage II drug approval process Phase I clinical trials

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1. The drug is given to 100-300 patients who have the target disease(testing may be restricted to a limited geographic area) 2. Includes positive control (placebo) in single-blind or double-blind studies ii. Focus: to determine if the drug produces therapeutic effects at dosages tolerated by patients with the target disease

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Stage II drug approval process Phase II clinical trials

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i. The drug is given to 1000-5000 or more patients who have the target disease. Testing occurs in many geographic areas ii. Includes placebo and double-blind studies iii. Focus: 1. To explore the full spectrum of beneficial actions of the drug 2. To compare the drug with older therapies a. To discover toxicity not detected in Phase I or Phase II clinical trials

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Stage II drug approval process Phase III clinical trials

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Stage II drug approval process Phase I clinical trials Focus:

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to study the effects of the drug in broad ranges of dosages

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Stage II drug approval process Phase II clinical trials Focus:

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to determine if the drug produces therapeutic effects at dosages tolerated by patients with the target disease

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Stage II drug approval process Phase III clinical trials Focus:

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1. To explore the full spectrum of beneficial actions of the drug 2. To compare the drug with older therapies a. To discover toxicity not detected in Phase I or Phase II clinical trials

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Stage IV drug approval process Focus:

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detection of adverse effects not evident in clinical trials

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established an abbreviated process for approval of generic versions of a previously-approved drug

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Drug Price Competition and Patent Term Restoration Act of 1984

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testing requirements are less stringent and the margin of safety is narrower for these

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priority drugs

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This legislation entitles the FDA to collect a substantial fee from the drug manufacturer at the time of NDA submission. In return for accepting the fee, the FDA is required to complete the review / approval process within an accelerated time frame.

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Prescription Drug User Fee of 1992

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What is the purpose of the United States Pharmacopoeia (USP)?

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compendium of information on drugs, including information regarding how each drug should be prescribed and administered.

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a system of nutrition recommendations from the Institute of Medicine (IOM) of the National Academies (United States).

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Dietary Reference Intake (DRI)

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three federal agencies charged with bioterrorism education, containment and preparation programs.

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a. Centers for Disease Control and Prevention (CDC) b. U.S. Department of c. U.S. Department of Homeland Security

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three potential risks to persons taking herbal products and specialty products

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a. Hypervitaminosis, or toxic levels of vitamins, (Page 499) b. Drug interactions c. Potential adverse effects from allergies and potentially slightly poisonous ingredients

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two pieces of legislation that regulate herbal and specialty products, and explain the strengths and general weaknesses of the laws.

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1. Dietary Supplement Health and Education Act of 1994 2. Dietary Supplement and Nonprescription Drug Consumer Protection Act

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Companies marketing herbal and dietary supplements are now required to include contact information on the product labels for consumers to use in reporting adverse events. Companies must notify the FDA of a "serious adverse event," which is defined as any adverse reaction resulting in death, a life-threatening experience, inpatient hospitalization, a persistent or significant disability, or a birth defect. Companies must notify the FDA of any serious adverse event reports within 15 days of receiving such reports. The labels must accurately reflect what is in the product, which must be free of contaminants such as pesticides, toxins, glass, or heavy metals.

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Dietary Supplement and Nonprescription Drug Consumer Protection Act, which took effect in 2007

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Describe the role of the National Center for Complementary and Integrative Health

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"the usefulness and safety of complementary and alternative medicine interventions and their roles in improving health and health care."

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organic compounds required by the body in small amounts for growth and for the maintenance of normal metabolic processes Human cells cannot synthesize them

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Vitamins

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Inorganinc compounds that can serve many important and diverse functions in the body

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Minerals

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absorbed along with water in the digestive tract and readily dissolve in blood and body fluids Easy to absorb, but no storage capacity

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water-soluble vitamins

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cannot be absorbed in sufficient quantity in the small intestine unless they are ingested with other fats. Conditional absorbtion, good storage capacity

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Fat-soluble vitamins

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A drug can legally be sold even though a black box warning has been issued for it. True False

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True

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In which stage of the drug approval process does testing on humans begin?

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Stage II (Clinical Evaluation)

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A system of therapeutics based on the theory that "like cures like"; treatments are given that mimic the disease, and that are designed to stimulate the patient's own healing power:

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Homeopathy

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Agents or preparations made from organisms or their products and used as diagnostic, preventive, or therapeutic agents:

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Biologics

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Under current regulations, manufacturers of dietary supplements must test their products, and must prove that they are safe and effective. True False

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False

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Which of these is responsible for regulating the development, manufacture and sale of medications in the United States? A.U.S. Dept of Agriculture B.Food and Drug Administration (FDA) C.National Institutes of Health (NIH) D.Pharmaceutical companies

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Food and Drug Administration (FDA)

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A drug can be fast-tracked through the approval process if: A.The back-up of drugs awaiting approval reaches capacity B.The drug is for a condition affecting babies and children only C.The drug is for a high-mortality or high-impact condition D.The drug company can prove the drug will deliver high profit margins

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C.The drug is for a high-mortality or high-impact condition

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The lead agency for scientific research and information about therapies such as biofeedback and naturopathy in the United States:

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National Center for Complementary and Integrative Health

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From the list below, select the group which CANNOT be licensed to write prescriptions for medications in Texas: A.Veterinarians B.Physician assistants C.Physicians D.Pharmacists E.Dentists

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D. Pharmacists

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This legislation was passed after diethylene glycol was added to an antibiotic, resulting in numerous deaths in the U.S.; it mandates evaluation of the safety of drugs:

answer

Food, Drug and Cosmetic Act of 1938

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