SPAT THEORY FINAL REVIEW

Vocabulary flashcards covering key SPAT theory concepts from the notes.

Sterile dosage forms

Parenteral dosage forms administered by routes other than the GI tract and includes:

1. injections,

2. suspensions,

3. sterile solids, radiopharmaceuticals,

4. infusion fluids,

5. diagnostic agents,

6. allergenic extracts,

7. irrigation solutions,

8. dialysates,

9. ophthalmic solutions.

Parenteral

Sterile dosage forms administered outside the GI tract.

injection routes

include IM, ID, IT, IA, IS, IP, Intravitreal, and IC.

National regulatory bodies

Health Canada; Food and Drugs Act (FDA);

National Association of Pharmacy Regulatory Authorities (NAPRA);

Canadian Society of Hospital Pharmacists (CSHP);

USP <797> & <800>.

Provincial/territorial regulatory bodies

examples include the Newfoundland and Labrador Pharmacy Board (NLPB).

Policy on Manufacturing and Compounding Drugs in Canada

Federal Health Canada policy distinguishing compounding from manufacturing; applies to all health care professionals;

covers human and veterinary use; includes scheduled drugs under the FDA.

Model Standards for Pharmacy Compounds

Categories: Non-sterile preparations; Hazardous sterile preparations; Non-hazardous sterile preparations.

Facilities

Environmental controls for sterile preparation: separate rooms, air quality, suitable physical structure, temperature and humidity controls, essential equipment, access restrictions; includes Non Aseptic Activity Room and Drug Storage Room.

Anteroom

Controlled area (ISO class 8 or higher) in front of the cleanroom; where personnel perform handwashing and garbing before entering the cleanroom.

Cleanroom

Area where actual compounding occurs; houses primary engineering controls like the Laminar Airflow Hood (LAFH); layout varies by risk level; nonporous, chemical‑resistant, easy to clean surfaces.

Personal Protective Equipment (PPE)

Covers to maintain sterility and safety: hair cover, shoe cover, gloves, mask, beard/mustache cover, gown, scrubs, and goggles/protective eyewear.

Horizontal Laminar Airflow Workbench (LAFW)

HEPA filter at the back; air flows toward the operator; suitable for non-hazardous sterile prep; features external gauge and a horizontal bar to hang items.

Vertical Laminar Airflow Workbench (LAFW)

HEPA filter on top; air flows downward; exhaust via front/back grilles; suitable for nonhazardous and hazardous sterile products; external gauge.

Biological Safety Cabinet Class 1

HEPA filter on exhaust; protects personnel and environment; not suitable for sterile product preparation; open working area.

Biological Safety Cabinet Class 2

HEPA filter on intake and exhaust; protects product, environment, and personnel; suitable for sterile products; usually housed in a cleanroom; open working area.

Biological Safety Cabinet Class 3

Totally enclosed, self‑contained workbench.

Infection control

Principles and practices to protect patients and staff: personal safety, infection prevention, preventing spread, and prevention from sources; includes facility housekeeping and equipment sanitization.

Alcohol disinfection

Intermediate-level disinfectant; typically 50–80% isopropyl alcohol; 70% common; higher concentrations evaporate quickly and reduce contact time; used for disinfection of gloves, stoppers, ports, and surfaces.

Injections

Parenteral medications in various dosage forms

Small Volume Parenterals (SVP)

Sterile powders reconstituted into solutions; usually not stable in solution;

Large Volume Parenterals (LVP)

Large-volume aqueous injections infused IV; used for fluid/electrolyte replacement and nutrition; vehicle for drug infusion.

Diagnostic agents

Injections to diagnose physiological changes or improve visualization in imaging; may contain dyes.

Needles

Various gauges/lengths; 18G common in sterile prep; 18G filter needle; safe uncapping/recapping required; recapping methods: two-handed or one-handed (preferred).

Needle recapping methods

Two-handed method and one-handed method (preferred) for safety.

Preloaded syringes

Ready-to-administer medications; used for crash cart drugs (e.g., epinephrine, lidocaine); EpiPen commonly cited.

Premixed minibag system

Premixed stable drugs in minibags (50–250 mL); may be liquid or frozen; advantages: reduces incompatibility and contamination and saves prep time; disadvantages: expensive, fixed quantities, limited availability.

Indications for Total Parenteral Nutrition (TPN)

GI disease (short bowel, Crohn’s, fistulas, etc.); malnutrition; hypermetabolic states; major organ failure; premature infants; inability to use oral feeding.

Fluids in PN

Water as a key component; body fluids distributed extracellularly and intracellularly (about 65% intracellular).

Calories in PN

Provide energy needs; influenced by clinical stress; main calories from dextrose and lipids.

Carbohydrates in PN (dextrose)

is the key carbohydrate, providing about 40–60% of total calories in PN.

Protein in PN (amino acids)

Amino acids provide protein for tissue maintenance and positive nitrogen balance; may also contribute calories.

Lipids in PN

Provide calories and essential fatty acids; roughly 20–50% of PN calories from this.

Zinc (trace element)

Essential for DNA, RNA, and protein synthesis; PN daily requirement ~2.5 mg.

Copper (trace element)

Integral part of oxidative enzymes; deficiency can cause anemia, leukopenia, bone disease in children; PN daily requirement ~0.2–0.3 mg; avoid with liver dysfunction.

Vitamin A

Fat-soluble; essential for retinal function and infection protection; daily dose ~3300 IU.

Vitamin D

Fat-soluble; important for calcium/phosphorus and bone metabolism; daily dose ~200 IU.

Vitamin E

Fat-soluble; strong antioxidant; PN dose ~10 IU.

Vitamin K

Fat-soluble; required for synthesis of coagulation factors; daily dose ~150 mcg or 5–10 mg weekly.

Thiamine (Vitamin B1)

Water-soluble; essential for neuronal function; daily dose ~3–6 mg.

Riboflavin (Vitamin B2)

Water-soluble; participates in oxidative enzyme systems; daily dose ~3.5 mg.

Niacin (Vitamin B3)

Water-soluble; essential for carbohydrate and protein metabolism; daily dose ~40 mg.

Folic acid and Vitamin B12

Water-soluble; nucleic acid synthesis;

Pantothenic acid

Water-soluble; helps prevent fatigue and mental disturbances.

Pyridoxine (Vitamin B6)

Water-soluble; coenzyme in amino acid metabolism; daily dose ~6 mg.

Vitamin C (Ascorbic acid)

Water-soluble; antioxidant; collagen synthesis and immune function; daily dose ~150–200 mg.

Biotin

Water-soluble; role in various enzyme systems; daily dose ~60 mcg.

PN Team roles

Physician, Pharmacist, Pharmacy Technician, Nurse, Dietitian.

Microbial testing of PN solutions

Solutions stored beyond 24 hours with 1–3 month expiry should be tested for microbial contamination by an outside laboratory.

Labelling requirements for PN admixtures

must include patient name, location, composition (amino acids, dextrose, lipid, electrolytes, trace minerals, vitamins, other meds), expiry date, storage conditions, and rate of infusion.

Cytotoxic drugs exposure mechanisms

Exposure can occur via inhalation, injection, absorption, and ingestion during handling and administration.

Safe handling of cytotoxic drugs – cleaning/decontamination

Work in well‑ventilated areas; decontaminate before/after activities; wear PPE; use appropriate cleaning agents.

Closed System Transfer Devices (CSTDs)

Devices used to reconstitute and transfer cytotoxic drugs to prevent escape of vapors, liquids, or powders.

ISO class 5 environment

Required for cytotoxic preparation; typically uses a vertical LAFH.

Negative pressure in cleanrooms

Air dynamics where the room is at negative pressure relative to surrounding areas; exhaust passes through HEPA.

Spill kits for cytotoxic drugs

Contain PPE, absorbents, hazard signs, bags, disposable tools, detergent, and emergency instructions; designed for immediate containment and cleanup.