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Legal and Regulatory Issues in Drug Administration: Laws and Life Span Considerations
Legal and Regulatory Issues in Drug Administration: Laws and Life Span Considerations
Under the law, nurses are RESPONSIBLE for their own actions regardless of whether
there is a written order.
Case: A doctor orders Morphine 500 mg instead of the standard Morphine 50 mg for a
patient post-surgery to relieve pain. The nurse administers it.
Analysis: - the doctor’s order was too high - the order was INCORRECT - the nurse
should have questioned the order
LEGISLATION 1912 – Sherley Amendment (to the Federal Food and Drug Act of 1906)
provided legislation prohibiting false therapeutic claims by drug companies in the
labelling of medication
LEGISLATION 1951 – Durham - Humphrey Amendment (to the Federal Food, Drug and
Cosmetic Act)
CONTENT
➢ clearly differentiated PRESCRIPTION and NON-PRESCRIPTION drugs
➢ opioids, hypnotics and tranquilizers can not be refilled without a new prescription
from a doctor
LEGISLATION Republic Act (RA) 9165 –the “Comprehensive Dangerous Drug Act of
2002“ (repealed RA 6425 – The Dangerous Drug Act of 1972) CONTENT
➢Enables the government to pursue an intensive and unrelenting campaign against the
trafficking and use of dangerous drugs and other similar substances through an
integrated system of planning, implementation and enforcement of anti-drug abuse
policies, programs, and projects
➢The government aims to achieve a balance in the national drug control program so
that people with legitimate medical needs are not prevented from being treated with
adequate amounts of appropriate medications, which include the use of dangerous
drugs
CULTURAL IMPLICATIONS
Nurses work in a diverse and multicultural environment.
➢ transcultural nursing practice
respect for patient’s values, beliefs, health practices, religion and spirituality
➢holistic nursing approach – integration of the patient’s mind, body and spirit in
providing care ➢influence of race, ethnicity and genetics – patients are unique and
respond differently to drug therapy
ELDERLY CLIENTS ELDERLY – absorb, distribute, and eliminate drugs less efficiently
they require a decrease in drug dosage
multiple diseases can exist – places increased risk for adverse drug reactions and
toxicities
poor compliance to take medications
patient teaching may be difficult due to sensory deficits and impairments
LEGAL AND REGULATORY ISSUES IN DRUG ADMINISTRATION
Knowledge of nursing practice – defines, specifies and limits the scope and functions
of the nurse
limits of the nurses’ knowledge and skills – professional conduct and training
MEDICAL ERRORS
➢ broad term used to refer to ANY ERROR in any phase of clinical patient care that
causes or has the potential to cause patient harm
➢ include
•Medications
•Medical or surgical procedures
•Patient monitoring
•Errors of commission
•Errors of omission
DEFINITION OF TERMS
• MEDICATION ERROR (ME) – refers to any PREVENTABLE adverse drug event
(ADE) involving inappropriate medication used by a patient or a health care professional
❖ may or may not cause patient harm
MEDICATION RECONCILIATION
➢ It refers to the FORMAL process in which health care professionals partner with
patients to ensure accurate and complete medication information transfer at interfaces
of care (WHO, 2007)
** Up to 67% of patients’ prescription medication histories recorded on admission to
hospital have one or more errors and 30 – 80% of patients have a discrepancy between
the medicines ordered in hospital and those they were taking at home.
➢ a PATIENT SAFETY initiative
➢ prevents omissions, duplications, incomplete, wrong drugs to be given
DRUGS AFFECTING THE CENTRAL NERVOUS SYSTEM (CNS) PART 1: OPIOID ANALGESICS GENERAL AND
LOCAL ANESTHETICS CNS DEPRESSANTS AND RELAXANTS
•both are the main centers where correlation and integration of nervous information occurs
•composed of large numbers of excitable nerve cells and their processes – NEURONS
➢PAIN – unpleasant sensory and emotional experience associated with actual or potential tissue
damage
•“whatever the person says IT IS, existing whenever the person says IT DOES
➢Pain acts as a protective mechanism that indicates an underlying physiologic or psychological problem
➢Pain is based upon a person’s perception, emotional state, and ethnic, cultural, or religious influences
ANALGESIA
OPIOID ANALGESICS
•Morphine
•Codeine
➢ OPIOID AGONISTS – drugs that bind to opioid pain receptors in the brain and cause an analgesic
response
Opioid receptors
•they compete with opioid agonists at receptor sites, hence blocking the effects of opioid agonists
Antagonists- occupy receptors but do not activate them, antagonists block receptor activation by
agonists.
INDICATIONS:
• Examples: Butorphanol, fentanyl, meperidine, morphine, nalbuphine, and pentazocine are used as
adjuncts to anesthesia (used post-operatively)
• Morphine is also used to treat pain in ***sickle – cell crisis and those caused by myocardial infarction
and pulmonary edema
CONTRAINDICATIONS:
- cough suppression
- respiratory depression
ABSORPTION
Central Nervous System (CNS)- SEDATION, disorientation, euphoria, light headedness, dysphoria,
increased seizure threshold, tremors
“MORPHINE”
“DESIGNER”
Dry mouth
Euphoria
Sedation
Itch
Gastro constipation
Nausea
Eyes (papillary constriction)
Respiratory depression
•NALOXONE (Narcan) – the drug of choice for complete or partial reversal of opioid-induced respiratory
depression
OPIOID INTERACTIONS
➢Concurrent use with alcohol, antihistamines, hypnotics or sedatives cause additional CNS depression.
➢Opioid agonist-antagonist may cause withdrawal symptoms in patients with physical dependence.
•allergies
•use of alcohol
➢Assess patient’s vital signs (BP, PR and RR) before administration and all throughout drug therapy.
➢To prevent withdrawal symptoms, discontinue opioid analgesics gradually after long-term use.
➢Instruct patient to take oral analgesics with food to minimize gastric irritation.
➢Teach patient to avoid activities requiring alertness (ex: driving) until the response of the drug is
known.
➢When administering Morphine and Meperidine, the nurse should withhold the dose and contact the
physician if the vital signs are abnormal, especially for a respiratory rate of <12 breaths/minute
•depression of consciousness
➢ ANESTHETICS – are the agents that depress the CNS to produce depression of consciousness, loss of
responsiveness to sensory stimulation and muscle relaxation
TYPES OF ANESTHESIA
•inhaled
•intravenous
LOCAL
➢ a drug-induced state of insensitivity to pain in a specific area of the body without affecting
consciousness
• parenteral
• topical
INHALED
➢ Halothane
➢ Isoflurane
INTRAVENOUS
➢ Ketamine
➢ Propofol
➢ Thiopental
➢ Methohexital
ADJUNCT AGENTS
➢ Fentanyl
➢ Meperidine (Demerol)
➢ Morphine
GENERAL ANESTHETICS
➢ CONTRAINDICATIONS – include
• known allergy
• respiratory depression
• cardiac depression
• Anti-hypertensives
• Beta-blockers
• Tetracycline
- Hypotension
- Myocardial depression
- Renal toxicity
➢ NURSING RESPONSIBILITIES
•Since anesthetics are given INTRA-OPERATIVELY, the responsibilities will be discussed in detail in LEVEL
3.
➢ CONTRAINDICATIONS – include
• known allergy
• for spinal and epidural – spinal headaches, hypotension, neural injury, transient back ache
• Bupivacaine
• Chloroprocaine
• Etidocaine
➢these are drugs that have a calming effect or depress the CNS
SEDATIVES – drugs that reduce nervousness, excitability and irritability without causing sleep
ANXIOLYTICS – drugs that basically effect calm and reduce panic or anxiety
Classifications:
2. Benzodiazepines
Hypnotic- diazepam, flurazepam, nitrazepam alprazolam, temazepam, triazolam
Antianxiety- diazepam, chlordiazepoxide, oxazepam, lorazepam, alprazolam
Anticonvulsant- diazepam, lorazepam, clonazepam, clobazam
CONTRA-INDICATIONS
allergies
pregnancy
respiratory depression
severe liver disease
NURSING RESPONSIBILITIES
➢Assess the patient for allergies, blood and liver function studies.
➢Administer drugs with meals to decrease GI upset.
➢Administer the drugs before bedtime to facilitate sleep.
➢Put bed side rails up after drug administration.
➢Observe patients for side and adverse effects while on therapy.
➢Assist the patients (especially geriatric) during ambulation in the morning.
NURSING RESPONSIBILITIES
Teach and inform the patient of the following:
• Take medication ONLY as prescribed. DO NOT double-dose.
• Take only for a short period of time as prescribed.
•Avoid taking other CNS-altering medications such as opioids and alcohol.
• Do not take with over the counter (OTC) medications.
•Avoid driving or engaging in activities that require alertness.
•Keep all medications away from children’s reach.
•Inform that such medications can cause dependence and interfere with sleep if taken long-term.
• Non-pharmacological interventions to promote sleep.
ANTI-CONVULSANTS (ANTI-EPILEPTICS)
ANTI-CONVULSANT DRUGS
➢these are also called “anti-epileptics”
➢used mainly for epilepsy and seizures
INDICATIONS:
•prevention and control of seizure activity
•maintenance therapy in patients with chronic seizures or epilepsy
MECHANISM of ACTION
•alter the movement of sodium, potassium, calcium, and magnesium ions resulting in stabilized and less
responsive cell membranes
•act to depress or limit the spread of a seizure discharge from its origin
•decrease the speed of nerve impulse conduction
ANTI-CONVULSANT DRUGS
Common examples: (on PRESCRIPTION ONLY)
➢ Benzodiazepines – 1 st line agents
•Diazepam – oral and parenteral forms
➢Hydantoins – management of tonic-clonic and partial seizures
•Phenytoin - oral and parenteral forms
•Carbamazepine – oral form
•Valproic acid – oral form
➢Barbiturates – prophylaxis for febrile convulsions
•Phenobarbital – oral and parenteral forms
CONTRA-INDICATIONS
•allergy
•pregnancy
NURSING RESPONSIBILITIES
•Oral drugs should be administered regularly at the same time each day.
•Administer oral drugs with meals to reduce GI upset.
•Give injections deep IM (usually in the gluteus).
•Give IV injections slowly and make sure IV line is patent or working well.
•DO NOT mix with other drugs and give IV injections separately.
•Monitor complete blood count (CBC) results as well as intake and output.
Teach and inform the patient of the following:
•Understand that drugs may be taken for life.
•Oral drugs should be taken regularly at the same time each day.
•Do not decrease dose or discontinue therapy without doctor’s order.
•Take the medication as ordered. DO NOT miss or double dose.
•Report any miss doses or problems immediately.
•The urine may turn pink when taking some of the drugs.
•Avoid driving or engaging in activities that require alertness.
•Encourage to always bring ID or medical bracelet.
ANTI-PARKINSONIAN DRUGS
•refer to the group of drugs that are indicated for the treatment and management of Parkinson’s
Disease (PD)
•PARKINSON’S DISEASE – a chronic, progressive degenerative disorder of the CNS affecting the
dopamine-producing neurons in the brain characterized by tremors or shaking
DOPAMINE RECEPTOR AGONISTS – are used to provide exogenous (outside source) of lost dopamine or
enhance the function of neurons still capable of producing dopamine
NURSING RESPONSIBILITIES
DOPAMINE RECEPTOR AGONISTS
Assess history of patients for seizures, hypotension, PUD, MI or asthma. These are all
CONTRAINDICATIONS to receive the drugs.
Assist the patient when walking because of dizziness at the start of therapy.
Instruct to avoid foods high in Vitamin B6, increase fluid intake, and eat high fiber foods.
SELECTIVE MAO INHIBITORS Monitor blood pressure and pulse before and during treatment.
Administer medicine at night or bedtime to avoid drowsiness at day time.
Avoid administering MAOIs with tyramine containing food such as milk, tea, cardbonated drinks,
wheat bread and cheese.
Observe mood swings during the treatment.
ANTI-CHOLINERGIC AGENTS
•Give the drugs or administer with meals or after meals to minimize GI upset.
•Facilitate intake of at least 2000 ml/day if not contraindicated.
•Instruct the patients on the following:
Avoid driving or activities requiring alertness.
Change positions slowly to prevent falling or injury due to orthostatic hypotension.
DO NOT discontinue treatment without consultation.
Avoid taking over-the-counter medications unless approved by the doctor.
PSYCHOTHERAPEUTIC DRUGS
➢these are also called “antipsychosis” or “neuroleptic agents”
➢used mainly for the treatment and management of mental and emotional disorders
➢ most of the drugs are considered CONTROLLED substances and follow the Scheduling Guidelines
Includes:
a. Amyl nitrate
b. Isosorbide nitrate
c. Isosorbide mononitrate
d. Nitroglycerin
Pharmacokinetics
a. Sublingual tablet
b. Translingual spray
c. Intravenous solution
d. Transdermal patch
Contraindications:
1. Severe Anemia
2. Head trauma or Cerebral Hemorrhage
3. Pregnancy and Lactation
Caution:
*Hepatic and Renal Disease
*Hypotension & Hypovolemia
Adverse Effects:
1. CNS
2. G.I.
3. CV
4. Skin-related
Drug-Drug Interactions:
1. Heparin
2. Drugs that treat Erectile dysfunction
Nursing Considerations
1. Assess: kidney or liver function, pregnancy and lactation
2. Check for neurological status, cardiopulmonary status, lungs
3. Monitor for lab tests
02 Beta Blockers
Therapeutic actions and indications
1. Use to block stimulatory effects of sympathetic nervous system
2. Recommended use for angina
Includes:
a. Metropolol
b. Propanolol
c. Nadolol *drugs ending in “lol”
Adverse Effects:
1. CNS
2. G.I.
3. CV
4. Respiratory
Drug-Drug Interactions:
1. Clonidine
2. NSAIDs
3. Insulin & Antidiabetics
NURSING CONSIDERATIONS:
1. Monitor ECG, heart rate
2. Monitor for I&O and weight gain
3. Teach patient not to abruptly stop taking the medication
Includes:
a. Amlodipine
b. Diltiazem
c. Nicardipine
d. Nifedipine
e. Verapamil
Pharmacokinetics
Oral preparations
Onset – 20 minutes
Contraindications:
1. Pregnancy or lactation Caution:
*Heart Block
*Sick sinus syndrome
*Heart Failure
*Renal or Hepatic Dysfunction
Adverse Effects:
1. CNS
2. G.I.
3. CV
4. Skin-related
Drug-Drug Interactions:
1. Cyclosporine
2. Digoxin
Nursing Considerations
1. Assess cardiopulmonary status, ECG
2. Check for liver function and renal function
3. Assess for respirations and auscultate lungs
Antiarrhythmic Drugs
Types:
1. Class I: antiarrhythmic
2. Class II: antiarrhythmic
3. Class III: antiarrhythmic
4. Class IV: antiarrhythmic
Class 1 antiarrhythmic
Includes:
3. Electrolyte Imbalance
Caution:
Adverse Effects:
1. CNS
2. G.I.
3. CV
4. Respiratory
Interactions:
1. Digoxin
2. Oral Anticoagulants
4. Grapefruit
Class II Antiarrhythmic
Includes:
a. Acebutolol
b. Esmolol
c. Propranolol
Pharmacokinetics
Contraindications:
Caution:
*Diabetes
*Thyroid Dysfunction
Adverse Effects:
1. CNS
2. G.I.
3. CV
4. Respiratory
Interactions:
1. Insulin
Drug of choice for treating ventricular fibrillation or pulseless ventricular tachycardia in cardiac arrest
Includes:
a. Amiodarone
b. Dofetilide
c. Ibutilide
d. Sotalol
Pharmacokinetics
Contraindications:
1. AV Block
Caution:
Adverse Effects:
1. G.I.
2. CV
Interactions:
1. Antihistamines, TCAs
Class IV Antiarrhythmic
Includes:
a. Diltiazem
b. Verapamil
Contraindications:
1. Hypotension Caution:
Adverse Effects:
1. CNS
2. G.I.
3. CV Interactions:
1. Beta Blockers
Nursing Considerations
TYPES OF HYPERTENSIVES
1. ACE INHIBITORS
Therapeutic Actions and Indications
1. Prevent conversion of Angiotensin I to Angiotensin II (powerful vasoconstrictor and stimulator
of aldosterone)
Pharmacokinetics
Oral Administration and IV solution
Contraindications, Adverse Effects, Drug-Drug Interactions
Contraindications:
1. Impaired renal function
2. Pregnancy
3. Lactation
Adverse Effects:
1. CV
2. GI
3. Skin-related
*Captopril
*Moexipril
Includes:
a. Candesartan
b. Irbesartan
c. Losartan
d. Telmisartan
Pharmacokinetics
Contraindications:
Pregnancy
Caution:
*Hepatic or renal dysfunction
*Hypovolemia
Adverse Effects:
1. CNS
2. G.I.
3. Respiratory
4. Skin
Drug-Drug Interactions:
1. Ketoconazole, fluconazole, Diltiazem
2. Phenobarbital, Indomethacin
3. VASODILATORS
Therapeutic Actions and Indications
1. Act directly on vascular smooth muscle to cause muscle relaxation
2. Treatment of severe hypertension
Includes:
a. Diazoxide
b. Hydrlazine
c. Minoxidil
d. Nitroprusside
Pharmacokinetics
Intravenous, Oral and IM
Adverse Effects:
1. CNS
2. G.I.
3. CV
4. Skin-related
5. Endocrine
*CYANIDE TOXICITY
OTHER HYPERTENSIVES
1. Diuretic Agents
2. Ganglionic Blocker
3. Renin Inhibitor
4. Sympathetic Nervous System Blockers
Diuretic Agents
❑ Drugs that increase the excretion of sodium and water from the kidney
1. Thiazide and Thiazide-like Diuretics
2. Potassium-sparing Diuretics
Ganglionic Blockers
❑ Used in severe or malignant HPN
❑ Monitor clients for loss of autonomic reflexes
1. Mecamylamine (Inversine)
Renin Inhibitor
❑ Inhibits RAS which may lead to decreased blood pressure, decrease aldosterone release, and
decreased sodium absorption
1. Aliskiren
1. Beta blockers
2. Alpha-adrenergic blockers
3. Alpha1- blockers
4. Alpha2- blockers
Nursing Considerations
2 Assess for the following conditions: kidney and liver function, pregnancy and lactation
01 Cardiac Glycosides
1. They exert their effects on the cardiac muscles by affecting levels of intracellular calcium. Digoxin
(Lanoxin)
Contraindications:
3. IHSS
4. Acute MI
5. Electrolyte Imbalance
Adverse Effects:
1. CNS
2. CV
3. GI
*Digitalis Toxicity
02 Phosphodiesterase Inhibitors
Includes:
1. Inamrinone
2. Milrinone
Contraindications:
2. Acute MI
1. CV
2. GI
3. Hematology
4. Hypersensitivity Recations
Nursing Considerations