Cultural, Legal, and Ethical Considerations

Cultural, Legal, and Ethical Considerations Jan Bazner-Chandler RN, MSN, CNS, CPNP

Federal Food and Drugs ACT • FFDA • Required drug manufactures to list on the drug product label the presences of dangerous and possible addicting substances. • U.S. Pharmacopeia

Drug Enforcement Administration • DEA is charged with the enforcement of Controlled Substance Act.

DEA • Individuals and companies legally allowed to handle controlled substances must register with DEA, keep accurate records of all transactions, and provide secure storage of drugs. • Physicians assigned number by DEA and must put number on all prescriptions of controlled substance.

DEA and the consumer • DEA will monitor the number of controlled substance prescriptions a consumer is using and from what physicians the prescriptions are being dispensed.

Schedule I Drugs • Drugs with high abuse risk. These drugs have NO safe, accepted medical use in the US. Some examples are heroin, marijuana, LSD, PCP and crack cocaine.

Schedule II Drugs • Drug with high abuse risk, but also have safe acceptable uses in the United States. These drugs can cause severe psychological or physical dependence.

Schedule II Drugs • Schedule II drugs include: certain narcotic, stimulant and depressant drugs. • Morphine sulfate • Cocaine • oxycodone (Percodan) • dextroamphetamine (Dexedrine) for Attention deficit disorder

Schedule II Drugs • Must be kept locked and signed out only by registered personal. • On the wards need key or code to gain access to medications – narcotics for pain relief.

Schedule II - prescription • At this time NP and PA do not have prescription writing ability. • In the hospitalized client narcotics often need to be re-ordered every 36 hours. • In the community – number of pills dispensed is regulated.

Schedule III, IV or V • Drugs with an abuse risk lower than Schedule II. These drugs also have safe and accepted medical use in the US. Drugs may contain safer and small amounts of certain narcotic and non-narcotic drugs, anti-anxiety, tranquilizers, sedatives, stimulants, and non-narcotic analgesics.

Schedule III Drugs • Schedule III: Less potential of abuse – • acetaminophen with codeine or Tylenol #3 • hydrocondone with codeine or Vicodin • diazepam or Valium

Schedule IV and V Drugs • Schedule IV: Appetite suppressant drugs • Schedule V: OTC pain medications

Student Nurse and Controlled Drugs • In the clinical you will always administer medication with the clinical instructor. • Narcotics cannot be accessed by student – must be done with instructor or registered nursing personal. • Specific hospital procedures and protocols need to be followed.

New Drug Development • Pharmaceutical industry is a multibillion dollar industry.

Drug Development • FDA approves studies – reviews lengthy testing protocol. • Animals • Randomized controlled studies on humans • Data collection • FDA approves drug for distribution

Food and Drug Administration • FDA • Purpose: to protect the patient and ensure drug effectiveness. • Responsible for approving drugs for clinical safety and efficacy before they are brought to market.

Marketing of Drugs • A billion dollar industry • New drugs are protected by patent for 14 years during which time only the pharmaceutical that has developed it can market it • After the fourteen years drugs with similar chemical composition can be developed and sold as generic drugs – cost less

Cost • Have you even wondered why a drug that costs pennies as an OTC can be so expensive when administered in the hospital setting? • The Tylenol given for fever may cost as much as $5.00 a pill • This pays for the processing of the physician order, pharmacy and the nurse that administers the drug

The Million Dollar Pill • Research! Research! Research!

Legal Issues and Nursing Implications Standards and scope and role of processional nursing.

Legal Framework • Federal and State Legislation • Standards of Care • Nurse Practice Act • Medication Administration

Ethical Practices • American Nurses Association Code of Ethics for Nurses • Serves as integral part of the foundation of professional nursing. • Ensures that the nurse is acting on behalf of the patient and with the patient’s best interest at heart.

Cultural Considerations “one size fits all”

Cultural Implications • Culture • Culture competence • Ethnicity • Ethnopharmcology • Race

Culture • An integrated system of beliefs, values, and customs that are associated with a particular group of people and are generally handed down from generation to generation.

Cultural Competence • The ability to work with patients with proper consideration for cultural context, which includes patients belief systems and values regarding health, wellness and illness. • It involves learning about different patients and their specific responses to treatment, including drug therapies.

Ethnicity • Ethnic affiliation based on shared culture or genetic heritage or both.

Ethnopharmacology • Study of the effects of ethnicity on drug responses, specifically drug absorption, metabolism, distribution, and excretion.

Race • Class of individuals with common lineage. Race is often used to refer to geographical origins of ancestry.

Ethnicity and Genetics Drug polymorphism

Drug Polymorphism • How the same drug may result in very different responses in different individuals.

What can influence response? • Age • Gender • Size • Body composition

What are cultural influences? • Level of patient compliance with the therapy regimen. • Cultural beliefs • Experiences with medications • Personal expectations • Family expectations • Family influence • Level of education

Alternative Therapies • Herbal • Homeopathic

Environmental Considerations • Diet • Malnutrition

Cultural Assessment • Health beliefs and practices • Past uses of medicine • Use of folk remedies • Use of home remedies • Use of over-the counter drugs – OTC • Usual response to illness • Responsiveness to medical treatment • Religious practices and beliefs • Dietary habits

Cultural, Legal, and Ethical Considerations