Drug Use, Regulation, And The Law

Front 1

What are the two factors neccessary to balance in regulating drugs?

Back 1

1. Individuals rights to live their lives as they desire
2. Society's obligation to protect it's members from the uncontrolled behavior

Front 2

What are the 2 Major guidelines for c ontrolling drug development and marketing?

Back 2

1. Society has the right to protect itself from the damaging effects of drug use.
2.Society has the right to demand that drugs approved for marketing be safe and effective to the general public.

Front 3

What was the 'Pure Food and Drug Act'?

Back 3

In 1906, meant to regulate food, but helped regulate drugs by requiring labels to indicate amounts of various drug substances contained in the food.

Front 4

What did the 'Sherley Ammendment' Do?

Back 4

Remedied the shortcommings of PF&D act by requiring that labels should not contain any statement misrepresenting the true nature and effects of a drug.

Front 5

what are Shortcommings still present in Pure food and drug act?

Back 5

the law requires government to prove fraud, which is difficult and still problematic. Pharmeceutical companies are now merely more vague in advertising products.

Front 6

What is the Federal Food, Drug and Cosmetic Act?

Back 6

Circa 1938, previos distinction between OTC and Prescription was non-narcotic vs. narcotic, after death of several people with OTC meds, Fed. government is given control over drug safety.

Front 7

What was the new definition of Drug under the Federal food, drug, and cosmetic act?

Back 7

Drug- includes products that affect the bodily structure or function even in the absence of disease.

Front 8

What was now required under the Federal Food, drug, and cosmetic act of companies?

Back 8

1.The drug label had to list all ingredients and include quantity of each
2.Provide instructions for safe use and warnings of dangers
3.Companies must file application to Feds for drug.

Front 9

What is the Durham-Humphrey Amendment?

Back 9

Amendment that established the criteria which are used today for determining whether a drug should be classified as prescription or non prescription.

Front 10

What are the 3 categories for considering a drug prescription or non prescription?

Back 10

1. The Drug is habit forming
2.The drug is not safe for self medication because of it's toxicity.
3.The drug is a new compound that has not been whon to be completely safe.

Front 11

What did the Kefauver and Harris Ammendments establish?

Back 11

Passed in 1962, sought to strengthen regulation by requiring drug manufacturers to demonstrate the efficacy and the safety of their drug products.

Front 12

Under the Drug Efficacy Research Council of 1966 what criteria were added to establish if a drug has been clinically verified? (4)

Back 12

1.Drug must be compared with Placebo
2.Compared to another drug known to be active based on previous studies
3.The established results of no treatment
4. and/or Historical data about the course of the illness without the use of the drug in question

Front 13

What are the requirements of the Federal Food, Drug, and Cosmetic act in force today? (3)

Back 13

New Drugs must-
1.Ensure the rigths and safety of human subjects during clinical testing
2.EValuate the safety and efficacy of new treatments based on results and information from health related companies
3.Compare potential drug benefts and risks to determine whether a new drug should be approved

Front 14

What are the Regulatory Steps for New Prescription Drugs? (3)

Back 14

1.Preclinical Research and Development
2.Clinical Research and Development
3.Permission to Market

Front 15

Explain the process of Preclinical Research and Development.

Back 15

A chemical must be identified as having potential value in the treatment of a particular condition or disease. Tests must be run on two or more animal species. Carcinogenic/mutagenic/and teratogenic variables are tested.

Front 16

Explain the Clinical Research and Development process.

Back 16

Tests conducted on humans.

Front 17

What are the 3 Phases of Clinical Research and Development on Humans?

Back 17

1. Initial Clinical Stage-small number of volunteers (20-10), including healthy people and patients
2. Clinical Pharmacological Evaluation Stage- Drug is tested to elimiate investigator bias and determing side effects/effectiveness on (100-300 patients) with medical problem drug is intended to treat participating in studies.
3. Extended Clinical Evaluation Stage- Drug effectiveness and danger is established, and is offered to a wider group of participating clinics and physicians who adminster to volunteer patients (1000s) Testing, safety checks are made and side effects are noted and send to FDA for approval.

Front 18

Explain the Permission to Market process of development.

Back 18

The Fda can allow the drug to be marketed under it's patented name, may cost $500 mil. and 8.5 years to develop new drug in U.S. Once drug is marketed it continues to be scrutinized for adverse effects.

Front 19

What is unofficial Phase 4 of this process?

Back 19

Post Marketing Surveillance of drugs.

Front 20

What are some exceptions to these regulatory steps?

Back 20

1. Fast-Track Drugs, drugs that are urgently needed are accelerated through evaluation.
2.Orphan Drug Law allows drug companies to receive tax advantages if they develop drugs that are not profitable because they are useful in treating small numbers.

Front 21

What did the Prescription Drug User Fee Act require of drug companies?

Back 21

Requires to pay fees to the FDA for evaluation of NDA's (Non-Disclosure Agreement) so that FDA can hire more reviewers to expedite reviews.

Front 22

What measures has the FDA taken in regulation of Nonprescription drugs?

Back 22

Program evalues the effectiveness and safety of non-prescription drugs by ensuring appropriate labeling and analyzing active ingredients.

Front 23

What are the 3 Categories of active ingredients in OTC drugs?

Back 23

1. Generally regonized as safe and effective for the claimed therapeutic indication
2. Not generally regocnized as safe and effective or unacceptable indications
3. Insufficient data available to permit final classification

Front 24

Whas has been the effect of OTC review on Today's meds?

Back 24

FDA bans manny OTC drug ingredients ruling ineffective or dangerous, this means safer and more effective OTC drugs.

Front 25

What is a 'Switching Policy'?

Back 25

Adopted by the FDA it allows the changeo f suitable prescription drugs to over the counter status. Brought on by pressure by public to make better drugs available for self medication.

Front 26

What are the 3 criteria that must be satisfied for a drug to be switched to OTC status?

Back 26

1. The drug must have been marketed by prescription for at least 3 years
2.Use of the drug must have been relatively high during the time it was available as a prescription drug
3.Adverse drug reactions must not be alarming and the frequency of side effects must not have increased during the time the drug was available to public

Front 27

What government entity regulates the advertising of OTC drugs?

Back 27

Federal Trade Commision (FTC), regulates validity of advertisement, but less strictly than rules for prescription meds.

Front 28

What complicates the econoomics of Prescription drugs?

Back 28

The second party of 'Physicians'.

Front 29

What is the relationship between drug promotion of consumes and drug promotion of physicians?

Back 29

Advertisement to individuals encourages them to urge prescriptions for various drugs, sometimes inappropriately. A large amouont of promotin is directed at health professionals but such is controlled by the FDA.

Front 30

What is the Wheeler-Lea Ammendment to the FTC ACT?

Back 30

The term false advertisement means an advertisement other than laveling which is misleading in a material respect.

Front 31

What is the relationship between public attitudes and the laws regarding drugs?

Back 31

Historically, laws have been modified or enforced according to public attitudes concerning drugs, whether it be wide public disapproval or so frequent use it is impossible to enforce the ban. As demonstrated by international law inconsistancy public opinion has much to do with what drugs are permissable and the strictness of reproach.

Front 32

What was the first Legitimate effort by the U.S. government to regulate addicting substances?

Back 32

The Harrison Act of 1914

Front 33

What was the Comprehensive Drug Abuse Prevention and Control Act of 1970?

Back 33

This act is the guideline by which law enforcement agencies deal with substance abuse, it divided substances with abuse potential into categories based on degree of abuse potential and clinical usefulness.

Front 34

Describe the categories the CDAPC divided substances with abuse potential into.

Back 34

These categories were called Schedules, there are schedules I through V, ranging from I being substances of high buse and no medical use to V being substances with low abuse and clinical use.

Front 35

What are some problems associated with implementation of drug laws?

Back 35

Unpopular/Restrictive laws rarely work to reduce the use of illicit drugs, they have little impact on level of addiction. Additionally, there is an insufficient number of law enforcement personnel and inadequate facilities, our legal system is not able process all criminals, and general morale is reduced because of these inefficiencies.

Front 36

What are the 3 principal issues influencing laws regarding drug abuse?

Back 36

1. If a person abuses a drug should he or she be treated as a criminal or a sick person?
2.How is the user distinguished(victim?) from the pusher(criminal?) and who should be more punished for the crime?
3.Are the laws and associated pentalies effective deterrents against drug use or abuse?