2535 Lecture 3: Legal/Ethical, Pt-Focused, Gene Therapy/Pharmacogenomics, Med Erros

canadian food and drug act

• primary legislation of governing food, drugs, cosmetics, med devises

• drugs must comply with official prescribed standards

• recognized formularies

• various schedules

controlled drugs and substances act (CDSA)

• replaced narcotic control act 1997

• provides requirement for control/sale of narcotics, controlled drugs, substance misuse 

• letter N and DIN symbol printed on label of every narcotic drug

• RCMP responsible for enforcement of CDSA

narcotic reconciliation (narcotic count) 

• see P&P at organization

• must be done every shift

• cannot leave until count is correct

marijuana use

• marijuana medical access program replaced in 2014 with marijuana for medical purposes regulation

• health canada regulates the producers of marijuana for this purpose but not involved in decision-making process

• consumed in resins, oils, extractions, edible formed, dried for smoking

new drug develpment

• ongoing process

• system of drug research and development most stringent in the world

• developed out of concern for pt safety and drug efficacy

• canadian national health products regulations (2003)

• health canada drug approval process

• once approved, drug assigned to DIN

4 clinical phases of investigational drug studies

• 1st, informed consent obtained

• phase I = small # of health subjects (fewer than 100)

• phase II = larger 3 of volunteers who have the disease or ailment (100-300)

• phase III = larger # of pt who are followed by medical research centres (1,000-3,000)

• phase IV = postmarketing studies voluntarily conducted by drug companies to obtain info of therapeutic and adverse effects of new drug

pt access to and cost of prescription drugs

• high drg expense significant barrier for access to prescription drugs that are not covered under Canada Health Act 

  • low income, no drug benefits, poor health

• OHIP+ = children and Youth Pharmacare 

special Access Programme

• allows health care providers compassionate access to drugs not available for sale in canada

• limited to those with serious or life-threatening conditions

legal nursing considerations

• nursing practice standards of care (CNO)

• scope of practice (RHPA)

• case law or common law consisting prior to court rulings

• CNA is national voice for nurses

• accreditation canada requires accredited hospitals to fulfill certain standards regarding nursing practice

liable for negligence and malpractice

• failure to assess or re-evaluate

• failure to ensure safety

• medication errors

ethical considerations

• ethical principles useful strategies

• autonomy, beneficence, nonmaleficence, justice, fidelity, veracity 

• CNA code of ethics for RN

• international council of nurses (ICN) code of ethics for nurses

legal and ethical nursing considerations

• safe, compassionate, competent, ethical care

• privacy and confidentiality

• promotion of justice

• accountability

• preservation of dignity

• informed decision making

• promotion of health and well-being

right of nurse to refuse care

• violates nurse personal ethical principles

• nurse speaks to supervisor/manager to request unit transfer, must not abandon pt

• nurse responsible for providing non-judgemental nursing care

• nurse always acts in best interest of pt while remaining objective to pt advocate

use of placebos

• drug dosage form without pharmacological activity

• exed in experimental drug studies

• considered unethical (creates mistrust among nurses, prescribers, pt)

• not specific formal guidelines 

use of placebos in research

• informed consent process followed

• pt informed of their right to

  • leave study without pressure/coercion

  • leave student with no consequences to medical care

  • receive full and complete info about study

  • made aware of alternative options and receive info on all treatments, including placebo therapy

drug therapy during pregnancy

• drug cross placenta via diffusion

• factors affecting safety

  • drug properties

  • fetal gestational age

  • maternal factors

• motherisk program

• US food and drug (FDA) implemented pregnancy safety categories

drug therapy during breastfeeding

• BF infants are at risk to exposure to drugs consumed by mother

• consider risk-benefit ratio 

absorption - neonatal/pediatric pharmacokinetics

• gastric pH acidic util 1-2 yrs

• gastric emptying slowed

• first-pass elimination reduced

• reduced bile salt formation decreases bioavailability

• intramuscular absorption faster and irregular

distribution - neonatal/pediatric pharmacokinetics

• total body water differences result in increased distribution and dilution of water (soluble drugs)

• greater total body water = lower fat content

• decreased level of protein binding = increased distribution

• immature blood-brain barrier = more drug enters brain

metabolism - neonatal/pediatric pharmacokinetics

• liver immature = not produce enough microsomal enzymes

• older children increased metabolism = higher more frequent doses than infants

• liver enzyme production

• genetic differences

• substance to which mother expose during pregnancy 

excretion - neonatal/pediatric pharmacokinetics

• kidney immaturity affects glomerular filtration rate and tubular secretion

• decreased perfusion rate of kidneys = reduced excretion of drugs 

factors affecting pediatric drug dosages

• skin in thin/permeable

• stomach lacks acid to kill bacteria

• lungs have weaker mucus barrier

• body temp less regulated, dehydration occurs easily

• liver and kidneys immature, imapring drug metabolism and excretion

methods of dosage calculations of PED pt

• body surface area method = west nomogram

• always use weight in kg, not Ibs

• always use height in cm, not inches

• body weight dosage cals = mg/kg 

Calculate the dose of amoxicillin suspension in mLs for otitis media for a 1-yr-old child weighing 22 lb. The dose required is 40 mg/kg/day divided BID and the suspension comes in a concentration of 400 mg/5 mL.

• Step 1. Convert pounds to kg: 22 lb × 1 kg/2.2 lb = 10 kg

• Step 2. Calculate the dose in mg: 10 kg × 40 mg/kg/day = 400 mg/day

• Step 3. Divide the dose by the frequency: 400 mg/day ÷ 2 (BID) = 200 mg/dose BID

• Step 4. Convert the mg dose to mL: 200 mg/dose ÷ 400 mg/5 mL = 2.5 mL BID

general considerations - peds med admin

• prepare all equipment and supplies 1st 

• have caregivers stay as appropriate

• assess for comfort methods before, during, after drug admin

  • infants

  • toddlers

  • preschoolers

  • school-aged children

  • adolescents 

considerations for older adult pts

• 65+

• high use of meds

• polypharmacy

• nonadherence

• increased incidence of chronic illnesses

• sensory/motor deficits 

absorption - older adults pharmacokinetics

• gastric pH less acidic

• gastric emptying slowed

• movement through GI tracts slowed b/c of decreased muscle tone and activity

• blood flow to GI tract reduced

• absorptive surface of GI tract reduced

distribution - older adults pharmacokinetics

• lower total body water percentage

• increased fat content

• decreased production of proteins by liver = decreased protein binding = increase circulation of free drugs

metabolism - older adults pharmacokinetics

• aging liver produces fewer microsomal enzymes 

• blood flow to the liver reduced 

excretion - older adults pharmacokinetics

• decreased glomerular filtration rate

• decreased number of intact nephrons 

older adults med requiring special considerations

• opioids

• nonsteroidal anti-inflammatory drugs (NSAIDs)

• anticoagulants

• antidepressants

• antihypertensives

• cardiac glycosides 

beers criteria for prevention of adverse drug events - older adults 

• listing of drug and drug classes to be avoided in older adults

• identified disease states considered to be contraindication for some drugs 

• three categories

  • potentially inappropriate drugs and classes in order adults

  • potentially inappropriate meds to avoid certain diseases

  • meds used with caution in older adults 

enthnopharmacy

• expanding body of knowledge for understanding  specific impact of cultural factors on pt drug response 

• hampered by lack of clarity in terms of race, ethnicity

• ethnocultural assessment needs to be part of the assessment phase of nursing process 

• not every pt from same country shares same culture 

ethnocultural influences and genetics on drug response

• polymorphism

• medication response depends on the level of pt adherence

• use of natural health remedies may alter a drug response 

• environmental and economic factors

• awareness of ethnocultural differences 

ethnocultural assessment

• languages

• health practices and beliefs

• past uses of medicine

• use of herbal treatment, folk/home remedies, natural health products

• use of over-counter drugs

• usual response to illness

• responsiveness to medical treatment

• religious practices and beliefs

• support for pt ethnocultural community 

• dietary habits 

ethnocultural nursing considerations and drug therapy

• important to be knowledgeable about drugs that may elicit varied responses in culturally diverse pts

• recognition that patterns of communication may differ

• thorough ethnocultural assessment needed

  • maintaining, protecting, restoring health

human genome project

• 1990-2003

• identified 30,000 genes, 3 billion base pairs in DNA of entire human genome

• improved prevention, treatment, cures for disease

• new tools for genetic data analysis and storage 

gene therapy

• experimental technique using genetic material to treat/prevent disease 

  • replacing mutated gene with a healthy copy of the gene

  • introducing a new gene into the body to help fight a disease

  • inactivating mutated gene that is functioning improperly 

gene transfer

• segments of DNA injected into pt body

  • recombinant DNA (rDNA) artificially produces DNA splices

limitations to gene therapy

• viruses used for gene transfer can induce viral disease and can be immunogenic in human host

• proteins produced by artificial methods can be immunogenic 

rDNA technology

• use of rDNA vectors in the lab to make recombinant forms of drugs

  • hormones, vaccines, antitoxins, monoclonal antibodies

  • Escherichia coli bacterial genome: used to manufacture a recombinant form of human insulin 

biologics and genetic therapies directorate of health canada

• oversees gene therapy research in canada

• eugenics: intentional selection before birth of genotypes that are considered more desirable than others 

• canadian gene therapy research limited to somatic cells only

• gene therapy in germ-line (reproductive) cells is currently not approved for funding in canada

pharmacogenetics

general term for the study of genetic variations in drug response

• focuses on single-gene variations

pharmacogenomics

combination of pharmacology and genomics

• involves how genetics (genome) affect the body’s response to drugs

• individualized drug therapy based on a pt’s genetic makeup

nursing implications

• take thorough pt, family, drug hx

• recognize situations that may warrant further investigation through genetic testing

• identify resources for pt

• teach pt

• maintain confidentiality and privacy

• ensure that informed consent is obtained

medication errors

• preventable

• common causes of adverse health care outcomes

• drugs commonly involved in severe medication errors

  • CNS

  • anticoagulants

  • chemotherapeutic drugs 

• more potential for harm with “high-alert” medications

adverse drug event

• medication errors

• adverse drug rxn (ADRs)

  • allergic rxn

  • idiosyncratic reaction

SALAD (sound-alike, look-alike drugs)

• cisplatin - carboplatin

• ephedrine - epinephrine

• fentanyl - sufentanil

• lantus - lente

• humalog - humulin

• novolog - novolin

• humulin - novolin

• humalog - novolog 

TALLman lettering

issues contributing to errors

• errors can occur during any step of med process

  • procuring

  • prescribing

  • transcribing

  • dispensing

  • administering

  • monitoring

• organizational issues

• educational system issues

• sociological factors

• use of abbreviations 

types of med errors

• near miss, although circumstances or events occured that could have led to an error

• no-harm error (med error causes no harm)

• medication error that causes harm

• critical incident (med error that results in serious harm)

preventing medication erros

• multiple systems of checks and balances should be implemented to prevent medication errors 

• prescribers must write legible orders that contain correct info, or orders should be entered electronically

• authorize resources such as pharmacists or current (past 3-5yrs) drug references or literature must be consulted 

• Nurses need to always check the medication order three times

  before giving the drug.

• Faculty members should not be the student’s research source

  regarding medications.

• The 10 rights of medication administration should be used consistently

responding to, reporting, and documenting med erros

• professional responsibility

• follow-facility policy

• follow-up procedures or tests

• nurses highest priority is pt physiological status and safety

• complete all necessary forms

• document with factual info (accurate, thorough, objective)

• avoid using judgemental words (ex) error)

• not observed changes in pt physical or mental status

• document that the prescriber was notified and any follow-up actions or orders that were implemented

• ongoing pt monitoring 

medication reconciliation

• continuous assessment and updating of pt med hx

  • verification

  • clarification

  • reconciliation

• designed to ensure that there are no discrepancies between what the pt was taking at home and in hospital

• process in which med are reconciled at all points of entry and exit from a heath care entity

• pt provide a list of all meds they are currently taking (including natural health products and over-counter drugs)

• should be done at each stage of heath care delivery

  • admission

  • statu change

  • pt transfer within/between facilities or provider teams

  • discharge (updated with latest meds)

ethical issues

preventing med errors

• assessment

• two pt identifiers

• do not admin if you did not draw-up or prepare yourself

• minimize verbal or telephone orders

  • repeat order to prescriber

  • spell drug name aloud

  • speak slowly and clearly

• list indication to each order

• avoid abbreviations

• never assume anything about items not specified in a drug order (ex) route)

• do not hesitate to question a medication order for any reason when in doubt

• do not try to decipher illegibly written orders (contact prescriber for clarification)

• NEVER use trailing zero with med orders (ex) NOT 1.0 mg, only 1 mg)

• ALWAYS uses leading zero for decimal doses

  • DO NOT use .25 mg, use 0.25 mg

• take time to learn special admin techniques for certain dosage forms

• always verify new med admin records

• always listen to and honour any concerns expressed by pt regarding med

• check all pt allergies and identification 

preventing pediatric med erros

• report all med errors

• know drug thoroughly

• follow 10 rights of med amin

• avoid verbal orders in general

• avoid distractions 

• communicate with everyone

• DOUBLE CHECK ALL CALCULATIONS