PHARM CHPT 1 & 2

center for drug evaluation and research (CDER)

Branch of FDA Determines safety and efficacy of drugs Pharmaceutical laboratories must solicit approval from FDA before marketing a drug

Center for food safety and applied nutrition (CFSAN)

Branch of FDA Oversees herbal and dietary products Regulation not as close as Food, Drug, and Cosmetic Act Herbal and dietary supplements can be marketed without prior approval from FDA; package inserts monitored once product is on market

Center for Biologics Evaluation and Research (CBER)

Branch of FDA Regulates use of biologics (serums, vaccines, and blood products) 1986 Childhood Vaccine Act result of CBER work

Are agents naturally produced by animals, microorganisms, or the human body

A client asks the nurse, "I read that the pill I am taking is a biologic. Is this some kind of special drug?" The nurse's explanation is based on the knowledge that biologics:

Potential for abuse (Rationale: Scheduled drugs are classified according to their potential for abuse. )

A client given a prescription for a Schedule III drug asks what the schedule means. The nurse explains that scheduled drugs are classified according to:

"This prescription is a higher dose than what is sold over the counter." (Rationale: Some drugs are available OTC in low doses but require a prescription at higher doses.)

A client given a prescription for ibuprofen (Motrin) says to the nurse, "I thought I could buy this over the counter (OTC)." The nurse explains:

"You are receiving a drug that by law cannot be refilled until you have another physician visit." (Rationale: There are no refills for Schedule II drugs without first being seen by the health care provider. This is a legal mandate, not controlled by insurance. "It is important for the physician to know how you are doing before you get another prescription" is true, but does not provide the best answer.)

A client is receiving a Schedule II drug, and is angry that the physician always says, "You must return to the office before I can give you another prescription." Which response by the nurse is most appropriate?

Access to them is easier. They do not interact with food and beverages.

A client prefers to purchase over-the-counter medications rather than prescription medications whenever possible. The nurse informs the client that advantages to using over the counter (OTC) meds include

"There is only one generic name for each drug. In this case, it is acetaminophen, so your pharmacist will give you that drug." (Rationale: There is only one generic name for each drug. "There is only one generic name for each drug. In this case, it is acetaminophen, so your pharmacist will give you that drug" provides an accurate explanation. Generic drugs do have same ingredients as brand-name drugs, although fillers and compression of the tablet may be different. The company marketing the drug gives the brand name.)

A client says to a nurse, "My nurse practitioner said the pharmacist should give me the generic drug instead of Tylenol. How will I know if it is the same drug?" Which response should the nurse make to the client?

Phase II (Rational: Phase II trials involve volunteer patients with the disease. Preclinical investigations do laboratory research; Phase I trials involve normal, healthy volunteers; and postmarketing surveillance is done after the drug is in use.)

A client tells the nurse, "I have been reading about research trials, and would like to be involved in one." The nurse asks the client if she has any documented diseases, knowing the client might be eligible to participate in which clinical trial phase?

Withdrawal symptoms (Rationale: This is a classic definition of withdrawal from a physical dependence on a drug. Discontinuation of a drug that causes physical dependence can cause withdrawal symptoms if the drug is not discontinued gradually. Euphoria and drug toxicity would not be expected. Anger can occur in the client, but this is not the best answer. )

A client who is physically dependent on a drug prescribed by a physician stops taking the drug. The nurse should anticipate that the client will experience:

Clinical investigation (Rationale: Phase 2 is the clinical investigation phase. It is in this phase that individuals are given drugs in the review process to appraise for adverse drug effects.)

A healthy, young client informs the nurse that she has enrolled in a clinical drug research study. The nurse recognizes the client is involved in which phase of trials?

high

A pharmaceutical company with exclusive rights to a drug often makes price very

Dependence

A physiological or psychological need for a substance

medication

After a drug is administered, it is called a

therapeutic effects, adverse reactions

All nurses administering medications monitor for _____________ __________________ and _______________ ________________from the drugs

Controlled Substance Act of 1970

Also known as Comprehensive Drug Abuse Prevention and Control Act Restricts use of drugs with potential for abuse Restricted drugs placed into the five schedules Hospitals and pharmacies must maintain complete records of scheduled drugs

Physical dependence withdrawal

An altered physical condition caused by the adaptation of the nervous system to repeated drug use When the drug is no longer available, the individual expresses physical signs of discomfort known as ______________

Category X Drugs

Animal and human studies have shown fetal abnormalities The drug is contraindicated in women who are or may become pregnant

Category B Drugs

Animal reproduction studies have not shown a fetal risk or adverse effect. Risks have not been confirmed in controlled studies in women

Pharmacological classification

Based on the way a drug works at the molecular, tissue, or body system level. It addresses a drug's mechanism of action, how a drug produces its physiological effect in the body.

Therapeutic classification

Based on usefulness in treating particular disease or disorders. Ex: antidepressant

Category A Drugs

Controlled studies in women fail to show a risk to the fetus, and the possibility of fetal harm appears unlikely

Dietary Supplement Health and Education Act, 1994

Controls misleading industry claims

rights issue

Depending on the state, a pharmacist may offer the generic form of a prescribed drug , or may only be allowed to dispense the exact form written in the prescription

reason for negative formulary list

Differences in bioavailability between generic and trade-name drugs Pharmaceutical companies and some health care practitioners support list Claim that differences could adversely affect patient outcomes

generic drugs

Drug companies lobby against easy substitution of

Therapeutic classification Pharmacological classification

Drugs are Organized in two ways

Scheduled Drugs

Drugs that have a significant potential for abuse are placed into five categories called schedules Schedule I drugs have the highest abuse potential, Schedule V the lowest

Category C Drugs

Either studies in animals have revealed adverse effects on the fetus and there are no controlled studies in women, or studies in women and animals are not available

Pure Food and Drug Act, 1906

Established government control of labeling medicines

Prescription Drug User Fee Act, 1992

Established on five-year trial basis Drug and biologic manufacturers provide drug-user fee FDA hired more employees FDA restructured organization Results Successful Doubled the number of drugs approved Some review times cut by half

Psychological dependence

Few signs of physical discomfort when drug is withdrawn, but intense compelling desire to continue drug use

Estonia 1847

First department of pharmacology established at what place in what year

Samuel Dale

First recorded reference to pharmacology in 1693 was by

Teratogenic Drug Classification

Five categories of risk that a drug poses to a fetus in the case of a pregnant woman taking the drug A, B, C, D, and X

USP and NF merge

Formed United States Pharmacopeia-National Formulary (USP-NF)

Schedule II Drugs

High abuse potential High potential for physical and psychological dependence Therapeutic use with prescription Some drugs no longer used

DEA (drug enforcment administration)

Hospitals and pharmacies must register with ___________ ______________ ____________ who regulates controlled substances. Must use assigned registration number to purchase scheduled drugs

review of new drug application (NDA)

If results of clinical investigation are positive, even if precautions are noted, a New Drug Application (NDA) is next step NDA is third step of drug approval process Average review time 17-24 months Drug approved: process continues Drug rejected: process suspended

Schedule IV Drugs

Lower abuse potential Lower potential for physical and psychological dependence Therapeutic use with prescription Alprazolam Clonazepam Clorazepate Diazepam Lorazepam

Schedule V Drugs

Lowest abuse potential Lowest physical and psychological dependence Therapeutic use without prescription Examples: OTC cough medicines with codeine

Schedule II-V Drugs

May be dispersed only in cases where therapeutic value has been determined Some Schedule V drugs may be dispensed without a prescription

Investigational New Drug Application (IND)

May be submitted for Phase I clinical trials when it is determined there are significant therapeutic benefits, and the product is reasonably safe for initial use in humans

Schedule III Drugs

Moderate abuse potential Moderate physical dependence High potential for psychological dependence Therapeutic use with prescription Some drugs no longer used Anabolic steroids Buprenorphine products Ketamine Benzphetamine

Chemical Generic Trade

Most drugs have three names

The Lengthy FDA Drug-Approval Process

NDAs can be massively long and FDA review can take several years Pharmaceutical manufacturer expenses for creating and marketing a new drug can be in the millions of dollars Core FDA goal is to ensure drugs are safe for the public

American Pharmaceutical Organization (APhA)

National professional society of pharmacists, established 1852 Maintained the national compendia of drug standards, the National Formulary (NF)

restrictions for schedule ii drugs

Need special order form to obtain Orders must be written by health care provider Orders must be signed by health care provider Telephone orders to pharmacies are not permitted No refills are permitted; patient must see health care provider first

Postmarketing surveillance

New drug placed on market Surveyed for harmful effects in larger population Diabetes drug troglitazone (Rezulin/ rejulin) is an example of a drug that did not exhibit harmful effects until the year after release FDA holds annual public meetings and Will withdraw a drug if serious problem found

they are more effective and have longer duration and favorable safety profiles

Newer drugs in the same class may replace the prototypes drug because they

tobacco, alcohol, and caffeine

Not All Drugs with Abuse Potential Are Regulated some are ...

postmarketing

Nurses participate most in the drug approval process during the______________ surveillance period of Phase IV

Food and Drug Administration (FDA)

Officially established in 1988 Agency of U.S. Department of Health and Human Services

black box warnings

One of the primary alerts for identifying extreme adverse drug reactions discovered during and after the review process ex: rezulin, celebrex website: Medwatch

Four Stages of Approval for Therapeutic and Biologic Drugs

Preclinical investigation Clinical investigation Review of new drug application (NDA) Postmarketing surveillance

Sherley Amendment, 1912

Prohibited drugs labeled with false therapeutic claims

FDA Modernization Act, 1997

Reauthorized Prescription Drug User Fee Act FDA Amendments Act expanded the reforms in 2007

prescription drugs disadvantages

Require a prescription to obtain Need for health care provider appointment

Schedule I Drugs

Restricted to situations of medical necessity, if allowed at all Little or no therapeutic value; mostly used for research Heroin Lysergic acid diethylamide (LSD) Methaqualone

Exact ingredients and strength of purity (Rationale: This reference includes drug monographs that summarize the standards of purity, strength, and directions for synthesis.)

The nurse can check the U.S. Pharmacopoeia: National Formulary to find which information about a drug that a client is receiving?

Prototype drug (Rationale: A prototype drug is the original well-understood drug model from which other drugs in a pharmacological class have been developed. Generic and brand names define only one particular drug. The therapeutic classification defines the condition for which the drug is used. )

The nurse can predict the actions and adverse effects of other drugs in the same pharmacologic class by understanding which of the following?

Whether the drug is effective (Rationale: In this phase, the clinical investigators address concerns such as whether the drug is effective, and whether it worsens other medical conditions.)

The nurse explains to a client that during the FDA drug approval process, clinical investigators from many different medical specialties address concerns such as:

The final stage of the approval process (Rationale: Postmarketing surveillance is best described as the final stage of the approval process. Laboratory research and testing are done before the drug is marketed, and involve the longest part of the application process.)

The nurse explains to a client that the phase postmarketing surveillance is best described as:

Potential for abuse and addiction is low. (Rationale: Schedule V has the lowest potential for abuse. They often are found in cough preparations.)

The nurse has administered a Schedule V drug to a client. When monitoring the effect, the nurse considers which potential effect of this schedule of drugs?

The pharmacological classification (reasoning: The pharmacologic classification of drugs explains the mechanism of action, or how a drug produces its effect. It explains how the drug works at the molecular, tissue, and body system levels. The therapeutic classification defines the drug's usefulness in treating a particular disease or condition.)

The nurse researches a new drug ordered for a client. In order to understand the drug's mechanism of action, the nurse checks to determine which of the following?

Addiction

The overwhelming feeling that drives someone to use a drug repeatedly

Category D Drugs

There is confirmation of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk Examples: In a life-threatening situation For a serious disease for which safer drugs cannot be used

Complementary and alternative medicine

These include natural plant extract, herbs, vitamins, mineral, dietary supplements, and vaccines. Physical therapy, manipulations, message, acupuncture, hypnosis, biofeedpack.

Food, Drug, and Cosmetic Act (1938)

Thorough testing of drug Proof of safety and efficacy of drug

generic

When rights end competing companies offer the ____________ form of the drug for less money

Drugs

a chemical agent capable of producing biologic responses may be desirable (therapeutic) or undesirable (adverse). It is also usually synthesized in a lab

Pharmacopoeia

a comprehensive medical reference manual summarizing and publishing drug standards

Pharmacoeconomics

a subdiscipline of health economics that helps assess factors involved in broad application of a particular drug therapy Examples: State and national debate about legalization of marijuana for the treatment of disorders

Biologics Control Act, 1902

act for Standardized serum and blood-related products. looked at vaccines, hormones etc.

Treat angina

antianginal

Influence blood clotting

anticoagulant

Restore normal cardia rhythm

antidysrhythmic

Lower blood cholesterol

antihyperlipidemic

Lower blood pressure

antihypertensive

Biologics

are agents naturally produced in animal cells, by microorganisms, or by the body itself. for example Hormones, monoclonal antibodies, natural blood products and components, interferons, and vaccines.

its cheaper

consumer advocates lobby for easy substitution of generic drugs bc

Combination drug

contains more than one active generic ingredient Rule of thumb is that active ingredients in a drug are described by their generic name which is lowercase

age, sex, body mass, health status, genetics

drugs elicit different reponses based on

Controlled Substances

drugs that: Are restricted by the Controlled Substances Act of 1970 and later revisions Are frequently abused Have a high potential for addiction or dependence Have restricted use Are placed into one of five schedules with one being the highest.

consumer advocacy

effort of ___________ _____________ advocacy groups have led to changes in or elimination of negative formulary list

John Jacob Abel

father of pharmacology, who also founded the first pharmacology department in United states at university of Michigan 1890

United states pharmacopeia (USP)

first comprehensive publication of drug standards summarized standards of drug purity, strength, directions for synthesis.

clinical investigation

has 3 different stages called phase trials and are the longest part of the approval stages first they try it on humans then on group with the disease then in diff groups, then apply for new drug application.

preclinical stage

involves extensive laboratory research, studies are performed in several species of animals to examine the drugs effectiveness at different dosages and look for adverse effects Results considered inconclusive

Therapeutic

is concerned with the prevention of disease and treatment of suffering

prototype drug

is the well understood drug model with which other drugs in its representative class are compared. • It is well understood • Has know action and adverse effects • It used to compare other drugs in the same pharmalogical class • May not be the most widely used drug in its class • Disagreements may exist over which drug should served

generic and trade

it is difficutl to tell a difference btw which two forms of drugs even when the dosage is the same

negative formulary list

list of trade name drugs in some states that pharmacist may not dispense as generic drug substitutes is called the

Pharmacology

study of medicine which encompasses how drugs are administered where drugs travel int he body response that drugs produce

Pharmacotherapy

the application of drugs for the purpose of treating disease and alleviating human suffering.

formulary

the first standard commonly used by pharmacists was the _________ or list of drugs and drug recipes

Prescription drugs Advantages

• Amount and frequency of drug is controlled • Health care provider or nurse determines a specific diagnosis and orders the proper drug • Instruction on use and side effects of drug are discussed

trade name

• Assigned by company marketing the drug • Short easy to remember • Also called proprietary, product, or brand name

generic name

• Assigned by the US adopted name council • Less complicated and easier to remember • Lowercase Each drug has one generic named used by may organizations -U.S. food and drug administration (FDA) -U.S pharmacopoeia -World health organization (WHO)

chemical name

• Assigned using standard nomenclature established by international union of pure and applied chemistry (IUPAC) • Describes physical and chemical properties of drug • Sometimes helpful in predicting a substances physical and chemical properties. • Often complicated and difficult to remember Ex: 7-chloro-1. 3-butyl ....

comparing generiv vs trade

• Inert ingredients may be different • Key to comparison is bioavailability the physiological ability of the drug to reach its target cells and produce its effects • Measuring how long a drug takes to exert its effect gives a crude measure of bioavailability.

Over the counter drugs (OTC) Advantages

• No health care provider appointment required • Often less expensive than prescription drugs

OTC drugs disadvantages

• Patient may choose wrong drug • Patient may not know reactions or interactions • Ineffective treatment may result in progression of disease