Pharmaceutics I - Exam One

What are the methods of treating illness?

Surgery, psychotherapy, physical therapy, radiation, and pharmacotherapy

What is the most frequent type of therapy used for treating disease?

Pharmacotherapy

T/F: The success of a procedure is only as good as the course of pharmacotherapy that follows.

True

What are two examples of epidemics?

(1) Bubonic plague in the 14th century

(2) Influenza from 1918-1919

Define "drug."

An agent intended for use in the diagnosis, mitigation, treatment, cure, or prevention of a disease

Do drugs have diversity in their actions?

Yes

Which quality of drugs enables them to be used in the treatment of a range of conditions?

Selectivity

New drugs can be derived from...

(1) Plant or animal sources

(2) By-products of microbial growth

(3) Chemical synthesis

(4) Molecular modification

(5) Biotechnology

Define dosage form.

The final physical form of a drug which may be used by the patient without requiring any further manufacturing

What are the two types of routes of administration?

Enteral and parenteral

What are the two types of enteral administration?

(1) Oral

(2) Rectal

How do drugs that are enterically administered get to the bloodstream?

By passing through the intestine

What is parental administration?

Administration of a medication that is absorbed outside of or beside the gastrointestinal tract

What is the main benefit of parental administration?

Avoidance of the first pass metabolism

What are the minor benefits of parental administration? (5)

(1) Targeted delivery

(2) Minimized toxicity/side effects

(3) Controlled administration rate

(4) Higher bioavailability

(5) Long-term treatment with a single dose

Describe absorption.

The drug is transferred from the dosage form to the blood or targeted tissue.

Describe distribution.

The drug travels through tissue and blood and into various organs and cells.

Describe metabolism.

Chemical changes made to the drug by the body and its elements

Metabolism is most often carried out by what organ?

The liver

Describe excretion.

Removal of a drug or the metabolites from the circulation and the body

Excretion most often occurs through what process?

Urination

Define pharmaceutics.

The blending of the basic, applied, and clinical sciences with pharmaceutical technology

Define bioavailability.

Rate and extent to which an active ingredient is absorbed and becomes available at the site of action and therefore gives a therapeutic response

What are excipients?

Pharmaceutically inactive materials

T/F: Excipients don't create side effects.

F; they can.

Name some examples of excipients.

Fillers, thickeners, solvents, suspending agents, tablet coatings, disintegrants, penetration enhancers, antimicrobial preservatives

A pharmacist is entrusted with the legal responsibility for what?

The procurement, storage, control, and distribution of effective pharmaceutical products and for the compounding and filling of prescription orders

What is compounding?

The preparing, mixing, assembling, packaging, and/or labeling of a drug formulation or device

What are the reasons for compounding? (3)

(1) As a result of a prescription drug order

(2) For the purpose of research, teaching, or chemical analysis

(3) In anticipation of prescription drug orders based on routine

State the part of the code of ethics presented by the American Pharmaceutical Association(APA) on professionalism.

A pharmacist has a duty to maintain knowledge and abilities as new medications, devices, and technologies become available and as health information advances.

Pharmacists are well-acquainted with the ___________ requirements for various drugs and drug products.

Storage

The pharmacist is the healthcare professional in the best position today to do what?

Know the various drugs a patient is taking and is best able to advise therapeutic effects

What are examples of factors of therapeutic considerations in dosage form design?

The need for systemic or local therapy, the duration of action required, whether or not the drug will be used in emergency situations, absorption based on administration route, whether or not the patient can swallow a pill, etc.

________ connection was commonly associated with the first drug-dispensing/compounding practitioners.

Spiritual/divine

From what term from the Homeric epics was pharmacy derived? What does it mean?

Pharmakon, which connotes a charm or drug that can be used for good or evil

Who discovered lactic acid, citric acid, oxalic acid, tartaric acid, glycerin, and arsenic acid?

Karl Wilhelm Scheele

In the 1930s and 1940s, what percentage of all medications were compounded?

60%

In the 20th century, pharmacists went from being known as ____________ to _______________?

Compounder; dispenser

In 2002, the FDA estimated that the number of compounded prescriptions is between ___% and ___%.

1; 8

T/F: recently, the amount of compounded drug preparations has decreased.

F; it has increased

What does the United States Pharmacoepia do?

Makes information on compounding and stability of compounded preparations and taken initiative to develop and publish monographs for compounded drug preparations

As the pharmaceutical industry became established, there were problems with what? (3)

(1) Quality control

(2) Questions of safety

(3) Unsubstantiated therapeutic claims

In what year was the first established pharmacoepia in the U.S. established?

1820

In 1888, what reliable source of drug information for professionals was established?

National Formulary

In what year was the first pure food and drug act passed?

1906

What was a major effect of the first pure food and drug act passed?

Sponsors were required to list a product's ingredients

When was the term "pharmacopeia" first used?

1580

What was the name of the first American pharmacopeia?

Lititz Pharmacoepia

Where and when was the first American pharmacopeia established? Why?

In 1778 at Lititz, Pennsylvania, for use by the Military Hospital of the US Army

The first American pharmacopeia contained how many internal and external drugs?

84 internal and 16 external

In 1808, the Massachusetts Medical Society published a pharmacopeia that was how many pages long? How many drugs did it contain monographs or information on?

272 pages and 536 drugs

Who is recognized as the father of the US pharmacopeia?

Lyman Spalding

In 1817, Lyman Spalding wrote a plan for the creation of a national pharmacopeia; what did it propose? (5)

(1) Divide the US into four geographic districts

(2) Have a convention in each district

(3) Invited delegates from medical societies and schools within each district

(4) Each district draft a pharmacopeia and appoint delegates for a convention in DC

(5) Compile each district's pharmacopeia into a national one at the convention in DC

When and where did the first US Pharmacopeial Convention assemble?

In Washington, DC, on January 1, 1820

The first United States Pharmacopeia was published when?

December 15, 1820

The first United States Pharmacopeia listed how many drugs?

217

When was the American Pharmaceutical Association organized?

1852

How did the National Formulary of Unofficial Preparations publish? When?

As a protest, a formulary was compiled of many popular drugs and formulas that were denied admission to the US pharmacopeia and published in 1888

How and when did the National Formulary get signed into law?

In 1906, President Theodore Roosevelt signed it into law in the first federal Pure Food and Drug Act

What does chapter 795 of the US pharmacopeia outline?

Nonsterile preparations

What does chapter 797 of the US pharmacopeia outline?

Sterile preparations

What does chapter 800 of the US pharmacopeia outline?

Handling hazardous drugs in healthcare settings

What does chapter 1136 of the US pharmacopeia outline?

Quality assurance in pharmaceutical compounding

The US pharmacopeia and national formulary adopt what to reflect the best in current practices of medicine and pharmacy?

Standards for drug substances, pharmaceutical ingredients, and dosage forms

What do monographs include?

Name, definition, packing, storing, labeling requirements, and specification

Homeopathic Pharmacopeia of the US is used by pharmacists, homeopathists, and law agencies to ensure the quality of ________ _________.

Homeopathic drugs

Which pharmacopeia was established by the World Health Organization?

International Pharmacopeia

Industry compliance with the standards of which organization is voluntary?

International Organization for Standardization

What was the first federal law in the US designed to regulate drug products manufactured domestically?

Food and drug act of 1906

In 1912, what did the Sherley Amendment to the Food and drug act of 1906 move to do?

Prohibit false claims of therapeutic effects of drugs

A highly toxic agent used in antifreeze solutions was once distributed in an elixir; what was the agent?

Diethylene glycol

What did the Federal Food, Drug, and Cosmetic Act of 1938 move to do?

Prohibit the distribution and use of any new drug or drug product without the prior filing of a New Drug Application and approval of the FDA, and required manufactured pharmaceutical products to be safe for human use

Did the Federal Food, Drug, and Cosmetic Act of 1938 require drugs or drug products to be efficacious?

No

Which act established a legal distinction between over-the-counter drugs and prescription drugs?

The Durham-Humphrey Amendment of 1951

Under the Durham-Humphrey Amendment of 1951, what requirement was made of prescription drugs?

The "Rx Only" symbol or the legend "Caution: Federal Law Prohibits Dispensing Without Presription"

What situation was one of many that brought about the Kefauver-Harris Amendments of 1962?

Thalidomide was being used as a sedative and tranquilizer, but when taken by pregnant women, it caused major birth defects, primarily phocomelia.

What did the Kefauver-Harris Amendments of 1962 mandate?

Demonstration of safety and efficacy of drugs and put emphasis on preclinical animal testing for teratogens and carcinogenicity assessment

According to the February 1993 report by the Congressional Office of Technology Assessment, how much does it cost to launch a new drug on average?

$359 million

Upon receipt of a new drug application, how much time does the FDA have to respond?

30 days

What are the sections within a new drug application?

Chemistry, preclinical results, and medical review

Describe the phases of the clinical trial phase of the drug approval proces.

(1) Phase I consists of administering the drug to a small population of healthy volunteers to learn how to administer the drug safely, monitor side effects, obtain initial dosing information, and initiate in vivo biopharmaceuticals.

(2) Phase II attempts to determine patient responses to a drug, tests several hundred people with a specific disease, and determine whether or not there is a useful therapeutic response.

(3) Phase III enrolls a large number of participants dispersed across many study sites.

Describe each part of the FDA review team and their jobs.

(1) Medical determines whether there is substantial evidence of the drug's effectiveness and demonstrates that the drug is safe.

(2) Chemistry reviews whether drug synthesis and manufacturing are properly controlled.

(3) Statistics provide consultation on trial design and evaluation.

(4) Clinical pharmacology determines the disposition and elimination in humans

(5) Pharmacology analyzes the disposition and toxicity of the drug target substance in animals and evaluates acute toxicity, teratogenicity, and carcinogenicity data

(6) Project management is the interface between the manufacturer and review staff

On average, how long does the preclinical phase of new drug approval take?

6.5 years

On average, how long does the clinical phase of new drug approval take?

7 years

On average, how long does the NDA review phase of new drug approval take?

1.5 years

T/F: Rare adverse reactions are likely to be found and identified during the clinical phase.

False

When was the Controlled Substances Act passed?

1970

Describe the criteria for schedule I drugs.

Drugs with no accepted medical use, or other substances with a high potential for abuse

What are examples of schedule I drugs?

Heroin, LSD, mescaline, marijuana, peyote, methaqualone

Describe the criteria for schedule II drugs.

Drugs with accepted medical uses and high potential for abuse that may lead to severe psychological or physical dependence

What are examples of schedule II drugs?

Morphine, cocaine, methamphetamine, amobarbital

Describe the criteria for schedule III drugs.

Drugs with accepted medical uses and a potential for abuse less than those listed in schedules I and II that if abused may lead to moderate psychologic or physical dependence

What are examples of schedule III drugs?

Codeine, hydrocodone

Describe the criteria for schedule IV drugs.

Drugs with accepted medical uses and low potential for abuse relative to those in schedule III that if abused may lead to limited physical dependence or psychological dependence

What are examples of schedule IV drugs?

Difenoxin, diazepam, oxazepam

Describe the criteria for schedule V drugs.

Drugs with accepted medical uses and low potential for abuse relative to those in schedule IV that if abused may lead to limited physical dependence or psychological dependence

What are examples of schedule V drugs?

Dihydrocodeine, diphenoxylate

A summary of the risks of using a drug during _______ _______ __________ include relevant information about pregnancy testing, contraception, and infertility for health care providers prescribing for females and males with reproductive potential.

Pregnancy and lactation

What are two important factors to consider when assessing the teratogenic potential of a medication when taken by a pregnant woman?

(1) The stage of pregnancy at which exposure occurred

(2) The amount of medication taken

A ___________ in prescription drug labelling is used to call attention to an adverse reaction so serious in proportion to the benefit that it could be considered in assessing the risks and benefits of using that drug, the risk of a serious adverse reaction can be prevented or reduced by careful use of the drug, or the FDA has approved of this drug with restrictions.

Black box warning