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34 Cards in this Set
- Front
- Back
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U.S Food and Drug Administration (FDA) |
•Approval of new drugs by the FDA has been steady since the early 2000s, reaching an all time high in 2014 with the approval of 44 new drugs |
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Critical Path Initiative |
•In order to facilitates the increase of approved drugs in 2004, the FDA established its Critical Path Initiative, a national strategy “to drive innovation in the scientific processes through which medical products are developed, evaluated and manufactured.”’ |
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Core Ethical Principles |
•Three core ethical principles are relevant to research involving human subjects: -Respect for person -Beneficence -Justice •These ethical principles are integral to the issues of informed consent and risk-benefit ratio in such research |
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Respect for persons |
•Patients should be treated as independent persons who are capable of making decisions in their own best interest •When making health care decisions, patients should be made aware of alternatives available to them as well as the consequences that stem from those alternatives •Autonomy is an integral component of respect for persons •Autonomy is the right to self determination •Patient can refuse any or all medications (right of autonomy) except when decision poses a threat to others-such as with tuberculosis, when taking medications is legally mandated |
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Informed Consent |
•It’s roots are in 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 •Informed consent has dimensions beyond protection of the individual patient’s choice: -It is a mutual sharing of info, a process of communication -It expresses respect for the person -It gains the patient’s active involvement in their care -It respects the patient’s right to self determination |
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Beneficence |
•Beneficence is the duty to protect research subjects from harm •It involves assessing potential risks and possible benefits and ensuring the benefits are greater than the risk |
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Risk-Benefit Ratio |
•The risk-benefit ratio is one of the most complex problems faced by the researchers •All possible consequences of a clinical study 📖 must be analyzed and balanced against the inherent risks and the anticipated benefits •A requirement of the Department of Health and Human Services (DHHS) is the institutional review boards (IRBs) determine that risks to subject be reasonable in relation to the anticipated benefits, if any, for subjects |
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Justice |
•Justice requires that the selection of research subjects be fair |
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Objectives and Phases of Pharmaceutical Research |
•The FDA requires clinical research to follow the Good Clinical Practice (GCP) Consolidated Guidelines, an international ethical and scientific quality standard for designing, conducting, monitoring, auditing, recording, analyzing and reporting clinical research |
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Preclinical Trials |
•Prior to the Implementation of clinical research, the FDA requires preclinical trials to determine a drug’s toxic and pharmacologic effects through in vitro and in vivo animals testing in the laboratory 🔬 |
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Human Clinical Experimentation |
•Clinical experimentation in drug research and development encompasses four phases, each with its own objective -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 |
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Clinical Research Study Design |
•An appropriate experimental design is important to answer questions about drug safety and efficacy •Studies are designed to determine the effect of the independent variable (treatment, such as the drug) on the dependent variable (outcome, such as clinical effects) •Intervening (extraneous) variables are factors that may interfere with study results and these may include: -Age -Sex -Weight -Disease state -Diet -The subject’s (person) social environment •It is important to control for as many of the intervening variables as possible to increase study validity |
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Scientific method (Pharmacology) |
•The experimental group in the drug trials is the group that receives the drug being test •The control group in drug trials may receive no drug (used for comparison) -This group receives a placebo (an inert drug) or same drug with different dose, route or frequency of administration |
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American Nurse Association (ANA) Code of Ethics |
•”Was developed as a guide for carrying out nursing responsibilities in a manner consistent with quality in nursing care and the ethical obligations of the profession.” |
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Federal Legislation |
•Federal legislation attempts to protect the public from drugs that are impure, toxic, ineffective or not tested before public sale |
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The Sherley Amendment (1912) |
•This act prohibited 🚫 false therapeutic claims on drug labels |
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The Harrison Narcotic Act (1914) |
•This act required prescriptions for drugs that exceeded set narcotic limits |
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The Federal Food, Drug and Cosmetic Act (1938) |
•The Federal Food, Drug and Cosmetic Act of 1938 empowered the FDA to ensure a drug was safe prior to marketing •It is the FDA’s responsibility to ensure that all drugs are tested for harmful effects •The Federal Food, Drug and Cosmetic Act of 1938 also required that drugs be labeled with accurate information and have detailed literature in the drug packaging that explains adverse effects |
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Durham-Humphrey Amendment (1951) |
•The Durham-Humphrey Amendment distinguished between drugs that could be sold with or without prescription by a licensed health care provider |
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Kefauver-Harris Amendment to the 1938 Act (1962) |
•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 |
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Drug Abuse Control Amendments (1965) |
•Enacted In 1965, the drug Abuse Control amendment attempted to control the abuse of depressants, stimulants and hallucinogens |
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The Comprehensive Drug Abuse Prevention and Control Act (1970) |
•In 1970, Congress passed the Comprehensive Drug Abuse Prevention and Control Act •This act was designed to remedy the escalating problems of drug abuse, including several provisions: 1-Promotion of drug education and research into 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 |
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Schedule Categories of Controlled Substances |
•Schedule I -Substances in this schedule have No currently accepted medical use in the United States, a LACK of accepted safety for use under medical supervision and a high potential for abuse Schedule II -Substances in this schedule have a HIGH POTENTIAL for abuse that may lead to severe psychological or physical dependence •Schedule III -Substances in this schedule have a potential for abuse less than substances in schedules I or II, and abuse may lead to moderate or low physical dependence or HIGH psychological dependence •Schedule IV -Substances in this schedule have low potential for abuse relative to substances in schedule III Schedule V -Substances in this schedule have a low potential for abuse relative to substances listed in schedule IV and consist of preparations containing limited quantities of certain narcotics |
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The Orphan Drug Act (1983) |
•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 |
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Dietary Supplement Health and Education Act (1994) |
•This act established labeling requirements for dietary supplements and authorized the FDA to promote safe manufacturing practices |
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Health Insurance Portability and Accountability Act (1996) |
•The Health Insurance Portability and Accountability Act (HIPAA) of 1996 protects health Insurance coverage for workers who change or lost their jobs and sets the standards for privacy of individually identifiable health information ℹ️ |
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The Food and Drug Administration Modernization Act (1997) |
•The five provisions in this act are 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 conditions 4-Drug companies are required to give information on off label (non-FDA approved) use of and their cost 5-Drug companies that plan to discontinue drug must inform health professionals and patient at least 6 months before stopping drug production |
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Best Pharmaceutical for Children Act (2002) |
•The BPCA gives manufacturers a 6-month extension of patients to evaluate drugs on the market for their safety and efficacy in children |
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Pediatric Research Equity Act (2003) |
•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.” |
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Food and Drug Administration Amendments Act (2007) |
•This act allows the FDA to do more comprehensive reviews of potential new drugs, mandates post marketing safety studies and affects the distribution of drugs found to be not as safe as premarket studies indicated |
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Patient Protection and Affordable Care Act (2010) |
•This act was signed into law in 2010 and became effective January 1, 2014. •The essential provisions of the reform include: 1-Quality, affordable health care for all Americans 2-Improves 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 |
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Food and Drug Administration Safety and Innovation Act (2012) |
•This act was signed into law on July 9,2012. •It strengthens the FDA’s ability to safeguard and advance public health by: -Collecting feed from industry to fund reviews of drugs with “breakthrough therapy” designation, medical devices, generic drugs and bio-similar 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 |
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Drug Names |
•Drugs have several names •The chemical name describes the drug’s chemical structure -The generic name is the official, nonproprietary name of the drug •The brand (trade) name, also known as the proprietary name, is chosen by the drug company and is usually a registered ® trademark |
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Over the counter Drugs |
•Are available for purchase without a prescription in many retail locations •All OTC drugs must have labels that provide the following information ℹ️ In This specific order: -The product’s 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 |
