Drug development & ethical considerations Flashcards
Autonomy
Right to make decisions for yourself
-R/T research means that pts have right to refuse to participate in study & can withdraw from study at any time without penalty
Informed consent
Pt has right to be informed of:
-purpose of study
-what is expected of pt
-potential consequences of participating in study
Participation always voluntary & without coercion
Beneficence
- Quality or state of doing or producing good
- Should be goal of each research study/clinical trial
Non-maleficence
Holds that there is an obligation not to inflict harm on others
Risk-benefit ratio
- Must balance risks with anticipated benefits
- IRB determines if benefits of research studies outweigh risks
Justice
- Requires equitable distribution of benefits, risks, costs, and resources
- Fairness
Pre-clinical drug testing
- Studies done on animals or human cells outside the body
- Studies drug’s toxic effects and pharmacological effects
- May look at pharmacokinetics & genotoxicity
In vitro testing
- Performed on human cells & tissues outside the body
- Not performed on living organisms
- Part of preclinical drug testing
In vivo testing
- Performed on whole, living organisms–usually animals
- Part of preclinical drug testing
NIH Revitalization Act
- 1993
- Ensured women & minorities included in clinical research
Best Pharmaceuticals for Children Act
Pediatric Research Act
- 2002 & 2003
- Required drugs marketed to children to be tested for for safety & effectiveness on children
- Recognized child’s response to drug not just effected by size & weight (children not just small adults)
Drug Research Phase I
- Drug or treatment tested on small group (20-100)
- Looks at drug safety, safe dosage range, & identifying side effects
- Usually given to healthy people with no underlying health conditions
Drug Research Phase II
- Drug or treatment tested on group of 100-300
- Looks at safety & effectiveness of new drug
- Given to study participants who have condition drug is meant to treat
Drug Research Phase III
-Drug tested on large groups (usually >1000) of
participants who have the condition that the new medication is meant to treat
-Trials in this phase can last for several years
-Evaluates how medication works compared to existing treatments
-Usually involves double-blind, randomized trials to eliminate bias in interpreting results
Drug Research Phase IV
- Studies drug after approved for marketing
- Looks at long-term affects & safety after widespread, long-term use in varied populations
Randomized controlled trials
- Most reliable way to evaluate drug therapy
- Makes sure differences in outcome result from drug treatment, NOT differences in subjects
- Prevents allocation bias (grouping pts by characteristics)
Double blind study
Neither researcher nor research subject know who is receiving experimental treatment
Experimental group
Receives drug/treatment being tested
Control group
May receive no drug, different drug, placebo, or same drug at different dose, frequency, or route
American Nurses Association Code of Ethics
- Adopted in 1950, last revision 2015
- Nurses’ primary ethical duty is to care for the patient
- Last revisions addressed ethical considerations R/T social media, EHR, & expanded nursing role in clinical research
United States Pharmacopeia & the National Formulary
- Authoritative source for drug standards in US
- Published annually
- Drugs included have met high standards of quality & safety
- USP often listed after drug name for included drugs
Nurse accountability–controlled substances
- Verify orders before drug administration
- Account for all controlled drugs
- Maintain log of controlled substances
- Document all discarded &/or wasted meds–must be witnessed by another licensed nurse
- Timely documentation of drug adm including pt response to medication
- Keep all controlled drugs in locked storage & narcotics under double lock
- Mandatory reporting of suspected or know drug diversion
Controlled substances-Schedule I
- No safe & accepted medical use
- Highest potential for abuse
- Ex: heroin, LSD, peyote, crack cocaine, PCP
Controlled substances-Schedule II
- High potential for abuse
- Has safe & accepted medical uses
- Includes combination products with <15 mg hydrocodone per dosage unit
- Ex: cocaine, morphine, oxycodone, methadone, hydromorphone, fentanyl
Controlled substances-Schedule III
-Less abuse risk than Schedule II
-includes combination products containing <90 mg codeine per dosage unit
Ex: acetaminophen with codeine, ketamine, anabolic steroids, testosterone
Controlled substances-Schedule IV
- Less risk of abuse & dependency than schedules I, II, & III
- Ex: alprozolam, carisoprodol, diazepam, lorazepam, tramadol, zolpidem
Controlled substances-Schedule V
- Lowest potential for abuse
- Primarily preparations containing limited quantities of certain narcotics
- Ex: cough preparations containing not more than 200 milligrams of codeine per 100 milliliters or per 100 grams (Robitussin AC, Phenergan with Codeine), diphenoxylate/atropine, pregabalin
Nurse Practice Acts
- Regulate nursing practice in each state
- Violation of nurse practice act can cause revocation of nursing license
- Nurses’ responsibility to know laws in state where they practice
Chemical drug names
- Describe drug’s chemical structure
- Not commonly used
- Ex: N-acetyl-para-aminophenol (Tylenol)
Generic drug names
-Only one name for each drug
-Not owned by drug company
-Same active ingredient as brand name drugs
-May have different inert ingredients–may affect bioavailability
-Require FDA approval
-Less expensive than brand name–clinical testing performed by company that developed drug initially
-No trademark, lowercase first letter
Ex: acetaminophen
Trade/brand drug names
- Name owned by drug company
- Same generic drug may have many trade names
- First letter capitalized, trademark follows name
- Usually easier to spell & pronounce than generic name
Responsibilities of FDA
Ensure drugs are:
- labeled correctly
- effective for condition marketed for
- safe
What are the three core ethical principles?
- Respect for persons (Autonomy)
- Beneficence
- Justice
Respect for Person’s (Autonomy)
-patients should be allowed to make their own decisions
Example of Fairness
When performing a drug study and one group is responding well to the drug, stop study and allow all people of the study groups to use the drug
Counterfeit Drugs
- may contain incorrect ingredients
- may have insufficient amounts of active ingredients
- May have no active ingredients
- May contain impurities and contaminants
- May be distributed in fake packaging
What is the nurses role when it comes to counterfeit drugs?
educate your patient about it
1912: The Sherley Amendment
- prohibits false therapeutic claims on drug labels
- Sherley had a product called soothing syrup that she advertised for teething and colic which led to many deaths of infants
1938: The Federal Food, Drug and Cosmetic Act
- had FDA make sure a drug was safe before marketing
- FDA is responsible for making sure drugs are tested for harmful effects as well as being labeled with correct information including adverse effects
1970: The Comprehensive Drug Abuse Prevention and Control Act
- Designed to lower problems of drug abuse by incorporating
1. promotion and research into prevention and treatment of drug abuse
2. Strengthening enforcement of authority
3. Establishment of treatment and rehabilitation facilities
4. Creating schedules for drugs based on abuse liability
1994: Dietary Supplement and Education Act
- dietary supplements classified as food
- FDA promote safe manufacturing practices
1996: Health Insurance Portability and Accountability Act
- HIPAA
- Protects workers health insurance when they change or lose jobs
- Sets privacy standard for individuals health information
2012: Food and Drug Administration Act
- Signed by law July 9, 2012
- Enhances safety of the global drug supply chains
