Advanced Pharmacology Chap.1

Critical Path Initiative, a national strategy “to drive innovation in the scientific processes through which medical products are developed, evaluated, and manufactured.”

10 to 12 years, with a cost of more than $1 billion for each drug

Respect for persons

Beneficence

Justice

self-determination

the 1947 Nuremberg Code.

The two most relevant aspects of the Code are the right to be informed and that participation is voluntary, without coercion

explain the study and what is expected of the patient to the patient and to respond to questions from the patient

protect research subjects from harm.

It involves assessing potential risks and possible benefits and ensuring the benefits are greater than the risk

fair

For example research subjects reflect all social classes and racial and ethnic groups

the Good Clinical Practice (GCP) Consolidated Guideline, an international ethical and scientific quality standard for designing, conducting, monitoring, auditing, recording, analyzing, and reporting clinical research

preclinical trials to determine a drug’s toxic and pharmacologic effects through in vitro and in vivo animal testing in the laboratory

genotoxicity, the ability of a compound to damage genetic information in a cell, in addition to drug absorption, distribution, metabolism, and excretion

include women and minorities in clinical research [only caucasian men were part of the trial]

study their drugs in children

Phase I: Researchers test a new drug or treatment in a SMALL group of people for the FIRST TIME to evaluate its safety, determine a safe dosage range, and identify side effects.

Phase II: The drug or treatment is given to a LARGER group of people to see if it is effective and to further evaluate its safety.

Phase III: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

Phase IV: Studies are done after the drug or treatment has been marketed to gather information on the drug’s effects in various populations and to assess any side effects associated with long-term use. Pharmaceutical companies are eager to bring new drugs to market.

expedite the review process [speed up approval of new drug introduction into the market]

As a result, the average drug approval time has decreased from 30 months to 12 months

the independent variable (treatment, such as with a drug) on the dependent variable (outcome, such as clinical effect)

Intervening (extraneous) variables are factors that may interfere with study results, and these may include

Age

Sex

Weight

Disease state

Diet

The subject’s social environment

a guide for carrying out nursing responsibilities in a manner consistent with quality in nursing care and the ethical obligations of the profession.”

It was first adopted in 1950 and most recently was REVISED with interpretive statements in 2015.

the United States Pharmacopeia (USP)

published annually

standards in strength and composition of drugs for use throughout the world

This act prohibited false therapeutic claims on drug labels

This act required prescriptions for drugs that exceeded set narcotic limits

The Federal Food, Drug, and Cosmetic Act of 1938 empowered the FDA to ensure a drug was safe prior to marketing

The Durham-Humphrey Amendment distinguished between drugs that could be sold with or without prescription by a licensed health care provider

The Kefauver-Harris Amendment resulted from the widely publicized thalidomide tragedy of the 1950s in which European patients who took the sedative-hypnotic thalidomide during the first trimester of pregnancy gave birth to infants with extreme limb deformities. The Kefauver-Harris amendment tightened controls on drug safety, especially experimental drugs, and required that adverse reactions and contraindications must be labeled and included in the literature.

Enacted in 1965, the Drug Abuse Control Amendments attempted to control the abuse of depressants, stimulants, and hallucinogens

In 1970, Congress passed the Comprehensive Drug Abuse Prevention and Control Act

This act, designed to remedy the escalating problem of drug abuse, included several provisions:

(1) promotion of drug education and research into the prevention and treatment of drug dependence

(2) strengthening of enforcement authority

(3) establishment of treatment and rehabilitation facilities

(4) designation of schedules, or categories, for controlled substances according to abuse liability

The Orphan Drug Act was designed to promote the development and manufacture of drugs used in the treatment of rare diseases (orphan drugs)

The act’s three primary incentives are

(1) federal funding of grants and contracts to perform clinical trials of orphan products

(2) a 50% tax credit for costs of clinical testing

(3) exclusive rights to market the drug for 7 years from the marketing approval date

This act established labeling requirements for dietary supplements and authorized the FDA to promote safe manufacturing practices

The Health Insurance Portability and Accountability Act (HIPAA) of 1996 protects health insurance coverage for workers who change or lose their jobs and sets the standard for the privacy of individually identifiable health information

(1) review and use of new drugs is accelerated

(2) drugs can be tested in children before marketing

(3) clinical trial data are necessary for experimental drug use for serious or life-threatening health conditions

(4) drug companies are required to give information on off-label (non–FDA-approved) use of drugs and their costs

(5) drug companies that plan to discontinue drugs must inform health professionals and patients at least 6 months before stopping drug production

The BPCA gives manufacturers a 6-month extension of patents to evaluate drugs on the market for their safety and efficacy in children

This act authorizes the FDA to require that drug manufacturers test certain drugs and biologic products for their safety and effectiveness in children, noting that “children are not small adults.”

This act authorizes the FDA to require that drug manufacturers test certain drugs and biologic products for their safety and effectiveness in children, noting that “children are not small adults.”

This act allows the FDA to do more comprehensive reviews of potential new drugs, mandates postmarketing safety studies, and affects the distribution of drugs found to be not as safe as premarket studies indicated.

This act was signed into law in 2010 and became effective January 1, 2014. Essential provisions of the reform include

(1) quality, affordable health care for all Americans

(2) improved quality and efficiency of health care

(3) prevention of chronic disease and improved public health

(4) improved access to innovative medical therapies

(5) community living services and supports.

This act was signed into law on July 9, 2012. It strengthens the FDA’s ability to safeguard and advance public health by:

•Collecting fees from industry to fund reviews of drugs with the “breakthrough therapy” designation, medical devices, generic drugs, and biosimilar biologic products

•Expediting development of innovative, safe, and effective products

•Increasing stakeholder engagement in FDA processes

•Enhancing the safety of the global drug supply chain

the drug’s chemical structure

the official, nonproprietary name for the drug; this name is not owned by any drug company and is universally accepted

the proprietary name, is chosen by the drug company and is usually a registered trademark

•The product’s active ingredients, including the amount in each dosage unit

•The purpose of the product

•The uses (indications) for the product

•Specific warnings, including when the product should not be used under any circumstances, substances or activities to avoid, side effects that could occur, and when it is appropriate to consult with a doctor or pharmacist

•Dosage instructions that include when, how, and how often to take the product

•The product’s inactive ingredients and important information to help consumers avoid ingredients that may cause an allergic reaction