Rigorously defined criteria, guidelines, and regulations mandated to ensure the safety, quality, efficacy, and proper marketing of medications
Drug standards are pivotal in verifying that pharmaceutical products strictly adhere to established specifications regarding composition, labeling, storage, and distribution
Nurses' comprehension and adherence to drug standards
Paramount to safeguard patient well-being, guarantee optimal therapeutic outcomes, and uphold legal and ethical practice standards
Implications for Nurses
Knowledge and Compliance
Patient Safety and Advocacy
Professional Responsibility
Knowledge and Compliance
Nurses are required to possess a comprehensive understanding of drug standards to ensure the accurate, safe, and effective administration of medications, in line with prevailing legal and ethical norms
Patient Safety and Advocacy
Proficiency in drug standards empowers nurses to champion patient safety, advocating for the provision of medications that meet the highest benchmarks of quality and safety
Professional Responsibility
Keeping abreast of drug standards is integral to a nurse's continuous professional growth and adaptation to evolving healthcare landscapes, research findings, and regulatory updates
Philippine Laws and Regulations for Medication Administration by Nurses
Republic Act No. 9173 (Philippine Nursing Act of 2002)
Republic Act No. 2382 (The Medical Act of 1959)
Republic Act No. 10918 (Philippine Pharmacy Act)
Administrative Order No. 2007-0027 (DOH Guidelines)
Department of Health Policies and Administrative Orders
Hospital and Institutional Policies
Philippine Guidelines/Laws
Philippine Food and Drug Administration (FDA)
Philippine National Drug Formulary (PNDF) and Related Laws
Quality Control and Drug Manufacturing Standards
Pharmacovigilance and Adverse Drug Reactions (ADRs)
Legal Framework for Drug Distribution and Administration
Patient Rights and Medication Safety
Drug
A chemical substance of known structure, other than a nutrient or an essential dietary ingredient, which, when administered to a living organism, produces a biological effect
Medication
A substance administered for the diagnosis, treatment, or relief of a symptom or for the prevention of a disease
Chemical Name
Describes the chemical structure (Eg: N-(4-hydroxyphenyl)acetamide = Acetaminophen Aka: Paracetamol)
Generic Name
The generally-agreed upon official name for a drug (Eg: Acetaminophen / Paracetamol)
Trade/Brand Name
The brand name/registered trademark (Eg: Tylenol / Panadol / Biogesic)
Pharmacodynamics
Describes the drug's effect on the body at the receptor level, including efficacy, potency, agonism and antagonism
Pharmacokinetics
The relationship between drug administration, time-course/rate of absorption & distribution, concentration changes in the body, and the drug's removal from the body
Agonist
A drug capable of binding and activating a receptor, leading to a pharmacological response that may mimic that of a naturally occurring substance. Can be classified as full, partial or inverse
Antagonist
Does not produce a biological response on binding to a receptor but instead blocks or reduces the effect of an agonist. It may be competitive or non-competitive
Efficacy
Used to describe agonist responses in relation to receptor occupation. High efficacy agonists can produce a maximal response whilst occupying a relatively low proportion of receptors
Half-life (t½)
The metabolic half-life of a drug in vivo is the time taken for its concentration in plasma to decline to half its original level. Clearance and distribution of a drug from the plasma are important parameters for half-life determination
Potency
Measure of the effective concentration of a drug. It is a vague term and it is advisable to further categorize the measurement
Nurses are responsible for following legal provisions when administering controlled substances (dangerous drugs)
Punishment = Fines/Imprisonment/Loss (revocation) of license
Examples of Controlled Substances/Drugs in the Philippines
Opioids (e.g., Morphine, Fentanyl)
Benzodiazepines (e.g., Diazepam, Alprazolam)
Stimulants (e.g., Methylphenidate, Amphetamine)
Barbiturates (e.g., Phenobarbital, Pentobarbital)
Cannabis (Marijuana)
Routes of Administration
Enteral Administration
Parenteral Administration
Topical Administration
Enteral Administration
The delivery of medication directly into the gastrointestinal tract, typically through oral, sublingual, buccal, or rectal routes, leveraging the digestive system for absorption
Parenteral Administration
The introduction of medication bypassing the gastrointestinal tract, commonly through intravenous, intramuscular, or subcutaneous routes, ensuring direct, often faster absorption into the systemic circulation
Topical Administration
The application of medication on the skin or mucous membranes, primarily for localized treatment but can also deliver drugs systemically through transdermal absorption
Choice of administration route depends on drug properties, desired onset, duration of action, pH of entry environment, & bioactivation requirements (eg: Prodrugs)
Considerations for Enteral (Peroral) Administration
Stability: Ability to withstand and remain effective under various conditions (e.g., acidic environment of the stomach)
Absorption Barriers: Capability to cross biological membranes and barriers to reach systemic circulation
Medication must resist degradation in the stomach's acidic conditions for enteral administration
Medication must have the ability to be absorbed in the intestines for enteral administration
Topical administration
Applied directly to the skin or mucous membranes; local or systemic effects
Topical applications
Antifungal creams (local)
Transdermal patches like clonidine (systemic)
Factors influencing route selection
Drug properties
Desired onset
Duration of action
pH of entry environment
Bioactivation requirements (e.g. prodrugs)
Chemical properties of medication
Stability: Ability to withstand and remain effective under various conditions
Absorption barriers: Capability to cross biological membranes and barriers to reach systemic circulation
Considerations for Enteral (peroral) administration
Acidic environment: Medication must resist degradation in the stomach's acidic conditions
Intestinal absorption: Ability to penetrate intestinal walls to enter the bloodstream
First-pass metabolism: Medications are often metabolized in the liver after absorption from the gastrointestinal tract, potentially reducing efficacy
Implications of First-pass metabolism
Efficacy reduction: Medications extensively metabolized into inactive forms in the liver may have reduced efficacy when administered orally
Route alternatives: For medications with significant first-pass effects, alternative routes like IV bypass the gastrointestinal tract and liver metabolism, ensuring direct delivery into the bloodstream and improved bioavailability
Dosing regimen
Schedule of dosage, including frequency and amount
Tailored based on patient's needs, medication properties, and route of administration
Factors influencing route selection
Chemical properties of medication
Absorption and metabolism considerations
Selection of the administration route and dosing regimen is critical for achieving desired therapeutic effects, minimizing adverse effects, and ensuring patient compliance