Chapter 2 Flashcards
Drug development and ethics (19 cards)
What is patient autonomy?
The right to self-determination. i.e. the patient has the right to make decisions even if the decision is not what the health care personnel advise.
If a patient has tuberculosis, can they refuse treatment?
No. The illness is a threat to others. Taking medications is legally mandated.
What is informed consent?
The right to be informed and that participation is voluntary, without coercion.
The duty to protect research subjects from hard. Ensuring the risks and possible benefits from participating in a research study are clearly defined.
Beneficence
What is required when ensuring beneficence?
The benefits outweigh the risks.
The selection of research subjects to be fair is a factor of what?
Justice.
Which drug class pertains to drugs that are not accepted for medical use in the U.S. due to a lack of safety and high potential for abuse.
Schedule I
Which drug class describes substaces that have a high potential for abse that may lead to severe psychological or physical dependence?
Schedule II
Which drug class describes substances that 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 III
Which drug class describes substance that have a low potential for abuse relative to substances in schedule III?
Schedule IV
Which drug class describes substances that have a low potential for abuse relative to substances listed in schedule IV and consist primarily of preparations containing limited quantities of certain narcotics?
Schedule V
Which drug class includes combination products with less than 15 mg of hydrocodone per dosage unit (cocaine, methamphetamine, methadone, fentanyl, methylphenidate)
Schedule II
Products containing less than 90 mg of codeine per dosage unit (acetaminophen with codeine), ketamine, anabolic steroids, testosterone.
Schedule III
Alprazolam, carisoprodol, diazepam, lorazepam, tramadol.
Schedule IV
Contain no more than 200 mg of codeine or per 100 mL (codeine/guaifenesin), diphenoxylate/atropine, difenoxin/atropine, pregabalin.
Schedule V
Describes the drug’s chemical structure.
Chemical name
Offical, nonpropreitary name for the drug; not owned by any drug company and is universally accepted
Generic name
Proprietary name, chosen by the drug company and is usually a registered trade mark.
Brand (trade) name
What variance percentage is acceptable for generic drug approval?
Less than 20% variance drug absorption, distribution, metabolism, and excretion. (Bioequivalent=therapeutic equivalent)
