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Pharmaceutics I > Ch1- Lec 1- Intro to Drug and Pharmacy > Flashcards

Ch1- Lec 1- Intro to Drug and Pharmacy Flashcards

1
Q

What is Pharmacy?

A

Pharmacy is the science, art, and practice of preparing, preserving, compounding, and dispensing medicinal drugs and of giving instructions for their use

How well did you know this?
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2
Q

Pharmacopeia’s or Formularies

A
  1. (First one in 1820) were created.
  2. These are organized sets of monographs or books of standards.
  3. Written with high degree of clarity and specificity
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

USP* and NF

A
  1. Adopt standards for drugs, pharmaceutical ingredients and dosage forms
  2. Reflect the best current practices of medicine
  3. Provides information on tests and assay procedures for demonstrating compliance with these standards
  4. For individual components not combinations
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

Pharmaceutical Care

A

“The mission of the pharmacist is to provide pharmaceutical care: “a practice in which the practitioner takes responsibility for a patient’s drug-related needs and is held accountable for this commitment”

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

Food and Drug Act of 1906:

A

Was the very first Federal Law in the U.S. that required that “drugs marketed interstate comply with claimed standards for strength, purity and quality”.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

Manufacturer’s claims of therapeutic benefit in 1912.
In this case, the Sherley Amendment said,

A

No More False Claims
Declared Products Misbranded

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

The Federal Food, Drug, and Cosmetic Act of 1938

A

What did it provide?

  1. Required that all new drugs be tested by their manufacturers for safety.
  2. Required that those tests be submitted to the government for marketing approval via the NDA (new drug application)
  3. Mandated that drugs be labeled with adequate directions
  4. Authorized FDA to conduct unannounced inspections
  5. No new drug could be distributed without the prior filing of a new drug application (NDA), and approval of the FDA.
  6. The FDA now dealt with safe use of drug substances, but did not require that the drugs be (efficacious) effective in the treatment of disease
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

The FDA was given the job to grant/deny products entering the market, based on

A
  1. Product’s ingredients
  2. Methods used to evaluate products
  3. Standards used to evaluate formulations
  4. Preclinical studies
  • Pharmacology
  • Toxicology
  1. Clinical trials
  2. Still, FDA did not require drugs to be efficacious
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

What is the difference between the FDA acts of 1906 and of 1938?

A

SAFETY

FDA Act of 1938- Required that all new drugs be tested by their manufacturers for safety..

FDA Act of 1906- dealt with strength, purity and quality of drugs

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

Kefauver-Harris Amendments of 1962

A
  • Thalidomide Tragedy was the main reason behind the development of this Act.
  • This amendment required manufacturers to prove a drug to be both safe as well as efficacious before granting FDA approval for marketing.
  • Exempted from both safety and efficacy requirements were drugs that happened to enter the market between 1906 and 1938 aka ~ grandfather clause. Why? Drugs were never subjected to NDAs.
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

Durham-HumphreyAmendment of 1952

A
  • No refills (dispensing of drugs) without a valid prescription
  • This clarified dispensing obligations of pharmacists
  • Defined drugs that cannot be used safely without proper medical supervision
  • Determined what drugs are OTC (over-the-counter) and what drugs are not available OTC
  • Refilling necessary only if authorized in prescription
  • Further supported by the drug abuse control amendments of 1965
  • and the Comprehensive drug abuse prevention and control Act of 1970.
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

Comprehensive Drug Abuse Prevention and Control Act of 1970

A
  • Drugs of abuse were put under a comprehensive regulatory framework
  • The act established 5 “schedules for classification and control of drug substances particularly those that were more likely to be abused
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

FDA Pregnancy Categories

A
  • 1979- US FDA introduced classification of fetal risks due to pharmaceutical agent use
  • What is the Risk vs Benefit Ratio?
  • Category A: Studies failed to demonstrate risk to fetus (1st trimester- no evidence of risk in later trimester)
  • Category B
  • Category C
  • Category D
  • Category X: Animal studies or humans demonstrated fetal abnormalities. Women outweigh potential benefits
  • See pg 15 (table 1 for known teratogens)
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

“Black Box” Warnings

A
  • FDAs absolute strongest labeling requirements used for the highest risk medications.
  • It stresses importance of close patient monitoring when using the medications.
  • No “reminder ads” for health care professionals allowed
  • Local and State Law may only strengthen FDA laws, never weaken them.
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

Schedule I, II, III, IV & V

A
  • The schedules provide decreasing levels of control from schedule I to schedule V.
  • Schedule I & II are high potential: ex.Heroin for schedule I
  • Schedule III is moderate potential: ex. Codein
  • Schedule IV&V are low potential: ex. Diazepam for schedule IV__________________________________________
    Examples were taken directly from text. See notes and Chapter #1 (page 13-14 ) for other examples
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

Drug Listing Act of 1972

A
  • “Each firm that manufactures or repackages drugs for the ultimate sale or distribution to patients or consumers must register with the FDA and submit appropriate information for listing”
  • National Drug Code (NDC) permanent registration code to identify manufacturer or distributor.
  • The code is 10 digits long
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
17
Q

National Drug Code (NDC)

A

** “Labeler code” “Product code” “Package code”**

** How is one different from the other?
Example of NDC: NDC 0081-5421-12**

Labeler code: Manufacturer/ distributor (1st 4 digits)
Product code: Used to identify drug formulation (3-4)
Package code: Used to identify package size & type (3-2)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
18
Q

National Drug Code

A

** NDC 0081-5421-12**

Represents 4-2 digit product-code-package-code configuration

** NDC 0057-346-421**

Represents 3-3 digit product-code-package-code configuration

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
19
Q

Drug Price Competition and Patent Term Restoration Act of 1984

A

A demand to change the speed for approving generic compounds
Generic drugs must be bioequivalent to brand-name drugs
This resulted in new modifications to FDA guidelines to “accelerate the approval of generic drugs, and to extend the life of innovative patented technology”
Ronald Reagen signed law on 9/24/84 to make generic drugs more widely available
Concerns of Pharmacists:

FDA criteria for bioequivalence, what about therapeutic index?

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
20
Q

Under the ANDA

A
  • In order to encourage pioneering research efforts and innovative drug development the life of patents was extended.
  • This time was extended to the amount of time required to review the NDA,
  • plus half the time required to evaluate the drug in the testing phase.
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
21
Q

Abbreviated New Drug Application (ANDA)

A
  • The Drug Price Competition and Patent Terms Restoration Act of 1984 said that,
  • “Any originally approved new drug can be filed through an ANDA and bypass animal and human study testing.”
  • This reduced the time and money to market the generic version of a drug compound.
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
22
Q

Prescription DrugMarketing Act of 1987

A

Aka “Dingell Bill”
This act prohibits reimportation of drugs, prohibits sales, trading and purchasing of drugs.

*******************Why important?****************
Functioned to protect the supply of prescription agents and prevent repackaged and mislabeled drugs from entering the legitimate market

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
23
Q

Dietary Supplement Health & Education of 1994

A
  • Due to growing interests in using dietary supplements, congress expressed the need to regulate all labeling claims.
  • Manufacturers had to state the following:
  • “This product is not intended to diagnose, treat, cure or prevent any disease”
  • Influences on body structure and function were okay
24
Q

FDA Modernization Act of 1997

A
  • First major overhaul of the FDA Act of 1938: Go to http://www.fda.gov or www.fda.gov/cder/fdama
  • Streamlined FDA policies
  • Codify agency’s newer regulations
  • Expanded patient’s access to investigational treatment for serious life-threatening diseases
  • Accelerated approval of new drugs
  • Pediatric use of investigational drugs was now made possible
25
Q

Code of Federal Regulations (CFR) and the Federal Register

A
  • Title 21 consists of eight volumes consisting of all regulations issued under the FDA cosmetic act and other statutes administered by the FDA
  • Updated each year
  • Most definitive information on Federal Laws and regulations pertaining to drugs.
  • Available on-line (www.access.gpo.gov/nara/cfr) and in print.
26
Q

Drug Product Recall

A
  • [FDA or manufacturer reveal that product presents threat to the public]
  • Class I: Exposure will cause serious adverse health consequences or even death
  • Class II: Exposure will cause temporary or medically reversible adverse health consequence
  • Class III: Exposure is not likely to result in adverse health consequences
27
Q

The Omnibus Budget Reconciliation Act of 1990

A
  • Effective January 1, 1993
  • Each state now expected to develop and mandate Drug Use Review (DUR) programs to improve quality of pharmaceutical care provided to patients.
  • Prescriptions fit needs of patients, are necessary, and should not cause adverse medical effects
  • State plan should request review of drug therapy prior to patient use
  • Pharmacists must maintain patient medication profiles and therapeutic counseling records
28
Q

Code of Ethics

American Association of Pharmaceutical Scientists

A
  • Conduct work in a professional manner- high principles are essential
  • No scientific misconduct tolerated
  • Recognize and respect differences in opinion in the interpretation of scientific data
  • Disclose sources of external conflicts
  • Report results honestly and accurately
  • Respect ownership rights of others and seek prior written approval from owner before disclosure
  • Do not discriminate on the basis of race, gender, creed or national origin
  • ** [See code of ethics on page 24 of chapter 1].**
29
Q

Pharmacy is the science, art, and practice of preparing, preserving, compounding, and dispensing medicinal drugs and of giving instructions for their use

A

What is Pharmacy?

30
Q
  1. (First one in 1820) were created.
  2. These are organized sets of monographs or books of standards.
  3. Written with high degree of clarity and specificity
A

Pharmacopeia’s or Formularies

31
Q
  1. Adopt standards for drugs, pharmaceutical ingredients and dosage forms
  2. Reflect the best current practices of medicine
  3. Provides information on tests and assay procedures for demonstrating compliance with these standards
  4. For individual components not combinations
A

USP* and NF

32
Q

“The mission of the pharmacist is to provide pharmaceutical care: “a practice in which the practitioner takes responsibility for a patient’s drug-related needs and is held accountable for this commitment”

A

Pharmaceutical Care

33
Q

Was the very first Federal Law in the U.S. that required that “drugs marketed interstate comply with claimed standards for strength, purity and quality”.

A

Food and Drug Act of 1906:

34
Q

No More False Claims
Declared Products Misbranded

A

Manufacturer’s claims of therapeutic benefit in 1912.
In this case, the Sherley Amendment said,

35
Q

What did it provide?

  1. Required that all new drugs be tested by their manufacturers for safety.
  2. Required that those tests be submitted to the government for marketing approval via the NDA (new drug application)
  3. Mandated that drugs be labeled with adequate directions
  4. Authorized FDA to conduct unannounced inspections
  5. No new drug could be distributed without the prior filing of a new drug application (NDA), and approval of the FDA.
  6. The FDA now dealt with safe use of drug substances, but did not require that the drugs be (efficacious) effective in the treatment of disease
A

The Federal Food, Drug, and Cosmetic Act of 1938

36
Q
  1. Product’s ingredients
  2. Methods used to evaluate products
  3. Standards used to evaluate formulations
  4. Preclinical studies
  • Pharmacology
  • Toxicology
  1. Clinical trials
  2. Still, FDA did not require drugs to be efficacious
A

The FDA was given the job to grant/deny products entering the market, based on

37
Q

SAFETY

FDA Act of 1938- Required that all new drugs be tested by their manufacturers for safety..

FDA Act of 1906- dealt with strength, purity and quality of drugs

A

What is the difference between the FDA acts of 1906 and of 1938?

38
Q
  • Thalidomide Tragedy was the main reason behind the development of this Act.
  • This amendment required manufacturers to prove a drug to be both safe as well as efficacious before granting FDA approval for marketing.
  • Exempted from both safety and efficacy requirements were drugs that happened to enter the market between 1906 and 1938 aka ~ grandfather clause. Why? Drugs were never subjected to NDAs.
A

Kefauver-Harris Amendments of 1962

39
Q
  • No refills (dispensing of drugs) without a valid prescription
  • This clarified dispensing obligations of pharmacists
  • Defined drugs that cannot be used safely without proper medical supervision
  • Determined what drugs are OTC (over-the-counter) and what drugs are not available OTC
  • Refilling necessary only if authorized in prescription
  • Further supported by the drug abuse control amendments of 1965
  • and the Comprehensive drug abuse prevention and control Act of 1970.
A

Durham-HumphreyAmendment of 1952

40
Q
  • Drugs of abuse were put under a comprehensive regulatory framework
  • The act established 5 “schedules for classification and control of drug substances particularly those that were more likely to be abused
A

Comprehensive Drug Abuse Prevention and Control Act of 1970

41
Q
  • 1979- US FDA introduced classification of fetal risks due to pharmaceutical agent use
  • What is the Risk vs Benefit Ratio?
  • Category A: Studies failed to demonstrate risk to fetus (1st trimester- no evidence of risk in later trimester)
  • Category B
  • Category C
  • Category D
  • Category X: Animal studies or humans demonstrated fetal abnormalities. Women outweigh potential benefits
  • See pg 15 (table 1 for known teratogens)
A

FDA Pregnancy Categories

42
Q
  • FDAs absolute strongest labeling requirements used for the highest risk medications.
  • It stresses importance of close patient monitoring when using the medications.
  • No “reminder ads” for health care professionals allowed
  • Local and State Law may only strengthen FDA laws, never weaken them.
A

“Black Box” Warnings

43
Q
  • The schedules provide decreasing levels of control from schedule I to schedule V.
  • Schedule I & II are high potential: ex.Heroin for schedule I
  • Schedule III is moderate potential: ex. Codein
  • Schedule IV&V are low potential: ex. Diazepam for schedule IV__________________________________________
    Examples were taken directly from text. See notes and Chapter #1 (page 13-14 ) for other examples
A

Schedule I, II, III, IV & V

44
Q
  • “Each firm that manufactures or repackages drugs for the ultimate sale or distribution to patients or consumers must register with the FDA and submit appropriate information for listing”
  • National Drug Code (NDC) permanent registration code to identify manufacturer or distributor.
  • The code is 10 digits long
A

Drug Listing Act of 1972

45
Q

** “Labeler code” “Product code” “Package code”**

** How is one different from the other?
Example of NDC: NDC 0081-5421-12**

Labeler code: Manufacturer/ distributor (1st 4 digits)
Product code: Used to identify drug formulation (3-4)
Package code: Used to identify package size & type (3-2)

A

National Drug Code (NDC)

46
Q

** NDC 0081-5421-12**

Represents 4-2 digit product-code-package-code configuration

** NDC 0057-346-421**

Represents 3-3 digit product-code-package-code configuration

A

National Drug Code

47
Q

A demand to change the speed for approving generic compounds
Generic drugs must be bioequivalent to brand-name drugs
This resulted in new modifications to FDA guidelines to “accelerate the approval of generic drugs, and to extend the life of innovative patented technology”
Ronald Reagen signed law on 9/24/84 to make generic drugs more widely available
Concerns of Pharmacists:

FDA criteria for bioequivalence, what about therapeutic index?

A

Drug Price Competition and Patent Term Restoration Act of 1984

48
Q
  • In order to encourage pioneering research efforts and innovative drug development the life of patents was extended.
  • This time was extended to the amount of time required to review the NDA,
  • plus half the time required to evaluate the drug in the testing phase.
A

Under the ANDA

49
Q
  • The Drug Price Competition and Patent Terms Restoration Act of 1984 said that,
  • “Any originally approved new drug can be filed through an ANDA and bypass animal and human study testing.”
  • This reduced the time and money to market the generic version of a drug compound.
A

Abbreviated New Drug Application (ANDA)

50
Q

Aka “Dingell Bill”
This act prohibits reimportation of drugs, prohibits sales, trading and purchasing of drugs.

*******************Why important?****************
Functioned to protect the supply of prescription agents and prevent repackaged and mislabeled drugs from entering the legitimate market

A

Prescription DrugMarketing Act of 1987

51
Q
  • Due to growing interests in using dietary supplements, congress expressed the need to regulate all labeling claims.
  • Manufacturers had to state the following:
  • “This product is not intended to diagnose, treat, cure or prevent any disease”
  • Influences on body structure and function were okay
A

Dietary Supplement Health & Education of 1994

52
Q
  • First major overhaul of the FDA Act of 1938: Go to http://www.fda.gov or www.fda.gov/cder/fdama
  • Streamlined FDA policies
  • Codify agency’s newer regulations
  • Expanded patient’s access to investigational treatment for serious life-threatening diseases
  • Accelerated approval of new drugs
  • Pediatric use of investigational drugs was now made possible
A

FDA Modernization Act of 1997

53
Q
  • Title 21 consists of eight volumes consisting of all regulations issued under the FDA cosmetic act and other statutes administered by the FDA
  • Updated each year
  • Most definitive information on Federal Laws and regulations pertaining to drugs.
  • Available on-line (www.access.gpo.gov/nara/cfr) and in print.
A

Code of Federal Regulations (CFR) and the Federal Register

54
Q
  • [FDA or manufacturer reveal that product presents threat to the public]
  • Class I: Exposure will cause serious adverse health consequences or even death
  • Class II: Exposure will cause temporary or medically reversible adverse health consequence
  • Class III: Exposure is not likely to result in adverse health consequences
A

Drug Product Recall

55
Q
  • Effective January 1, 1993
  • Each state now expected to develop and mandate Drug Use Review (DUR) programs to improve quality of pharmaceutical care provided to patients.
  • Prescriptions fit needs of patients, are necessary, and should not cause adverse medical effects
  • State plan should request review of drug therapy prior to patient use
  • Pharmacists must maintain patient medication profiles and therapeutic counseling records
A

The Omnibus Budget Reconciliation Act of 1990

56
Q
  • Conduct work in a professional manner- high principles are essential
  • No scientific misconduct tolerated
  • Recognize and respect differences in opinion in the interpretation of scientific data
  • Disclose sources of external conflicts
  • Report results honestly and accurately
  • Respect ownership rights of others and seek prior written approval from owner before disclosure
  • Do not discriminate on the basis of race, gender, creed or national origin
  • ** [See code of ethics on page 24 of chapter 1].**
A

Code of Ethics

American Association of Pharmaceutical Scientists

Pharmaceutics I (7 decks)

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