APF26 Dispensing: Comprehensive Study Notes

APF26 Dispensing: Comprehensive Study Notes

APF26: Essential reference and scope

• APF26 is the Essential reference for practice and is mandated by the Pharmacy Board of Australia.

  • Pharmacists must be able to access the current APF when:

  • reviewing, dispensing, counselling, and during clinical assessments.

  • Includes information on:

  • Medicines safety and quality use of medicines

  • Dispensing and labelling

  • Compounding (good compounding practice and formulas)

  • OTC treatment guidelines for pharmacists

  • Other topics relevant to practice (e.g., complementary medicines, opioids, monitoring, pharmacokinetics, wound management)

APF26 in Dispensing

• Most products we make in class are APF products.

• Exam questions are drawn from APF.

Do I really need the latest version of APF?

• Yes!

• There are significant differences between editions that can affect practice, labeling, formulas, and guidance used in assessments.

Spot the difference … Spirono formulation example (Spironolactone mixture CF vs suspension)

• Two spironolactone liquid formulations shown in APF examples:

  • Spironolactone mixture CF (1 mg/mL spironolactone)

  • Components referenced: spironolactone, carboxymethylcellulose mucilage, syrup, compound hydroxybenzoate solution, purified water

  • Formulated by mixing solid spironolactone (or crushed tablets) with syrup and carboxymethylcellulose mucilage, then slowly adding hydroxybenzoate solution and portions of water; transfer to measuring flask; rinse; make to final volume; mix well.

  • Label: SHAKE WELL BEFORE EACH USE (Label J); REFRIGERATE; DO NOT FREEZE (Label 6). See Table A2, page 19.

  • Container: Amber glass bottle; protect from light.

  • Storage: $2-8^{\circ}\mathrm{C}$.

  • Expiry: $90\ ext{days}$ from date of preparation.

  • Handling: See cautions and advisories; see also notes about possible cancer association (context in text): pharmaceutical staff should use precautions.

  • Additional references: See Carboxymethylcellulose mucilage (p.53), Syrup (p.64), Compound hydroxybenzoate solution (p.69).

  • Spironolactone suspension (25 mg/mL)

  • Use crushed spironolactone tablets or pure spironolactone; vehicle for oral suspension USP-NF; triturate to a smooth paste; add remainder of vehicle; transfer to an amber bottle; rinse mortar with vehicle for oral solution; fill to final volume (100 mL).

  • Label: SHAKE WELL BEFORE EACH USE (Label J); REFRIGERATE; DO NOT FREEZE (Label 6). See also potential cautionary labels.

  • Container: Amber bottle; protect from light.

  • Storage: $25^{\circ}\mathrm{C}$ or below (specifically below 25 °C).

  • Expiry: $60\ ext{days}$ from date of preparation.

  • Handling: Spironolactone has been associated with cancers and feminisation of male offspring in rats; appropriate precautions.

  • Cautions/labels: SHAKE WELL BEFORE EACH USE; Amber bottle; Storage below $25^{\circ}\mathrm{C}$.

  • Further information: Other formulations exist (e.g., 2 mg/mL; 5 mg/mL); consult hospital pharmacy literature.

• Practical takeaways:

  • APF provides explicit preparation methods, labeling, container choice, storage, and expiry for compounded liquids.

  • The same API (spironolactone) can be prepared as different formulations with different concentrations, vehicles, storage, and expiry.

  • Always refer to the latest APF edition and page references (e.g., Table A2; p.19) when preparing and labeling.

The University of Sydney – APF: Key Sections

• Section: APF26 – Key Sections

  • Section/Info mapping: Section 2.3 – Recommended cautionary and advisory labels for medicines (Table 2.3)

  • Section 2.6 – Latin abbreviations used in prescription writing (Table 2.6)

  • Formulary: type of product information, labels, container and storage, expiry; dispensing records include formula to compound, container, and label details.

• Purpose: to help interpret prescriptions, prepare labels, and ensure consistent labeling across products.

APF: Key Sections (detailed)

• Table 2.3: Recommended cautionary and advisory labels for medicines

  • Outlines the recommended cautionary and advisory labels for medicines dispensed in class, and is tied to exam questions.

• Table 2.6: Latin abbreviations used in prescription writing

  • Outlines common Latin abbreviations used by prescribers to convey directions on scripts.

  • Helps in interpreting scripts and determining what directions to include on labels in labs/exams.

• Formulary

  • Type of product: general information, labels, container, storage, expiry.

  • Individual product: formula, method, strength of active ingredients, label, container, storage and expiry.

  • Dispensing records: find formula to compound, container type, and details (storage conditions, active ingredients, expiry date) to include on label.

Dispensing Manual: Overview

• Resource for all dispensing units in the School (and for future practice).

• Contains both information and sections to complete:

  • Glossary of pharmaceutical terms

  • Final containers used in the lab

  • Equipment used in lab

  • Properties of pharmaceutical ingredients

• Updated annually; access current version from Canvas.

Dispensing Manual: Key Sections

• General information (pg 7)

• Labelling dispensed medicines, including auxiliary labels

• Common abbreviations used in script writing

• The dispensing record

• PBS eligibility and the drug tariff

• Dispensing of specific dosage forms (pg 23)

  • E.g., liquids for internal use, capsules, ointments, creams and pastes, suppositories and dose forms for ear and nose

  • For each product: standard method, container, labeling info, and expiry date

• Appendices (pg 61)

  • Formulas from earlier editions of APF and USP

  • PBS prices

  • Properties of pharmaceutical ingredients

  • 2024 University Calendar

Dispensing Manual: Example – Simple mixtures (Liquids for Internal Use)

• Section: 2. LIQUIDS FOR INTERNAL USE - MIXTURES, VEHICLES AND INFUSIONS

• MIXTURES: definition and scope

  • A "mixture" is a liquid preparation for oral administration where medicaments are dissolved or suspended in an essentially aqueous vehicle.

  • The label for a product as a mixture indicates internal use.

• Categories: SIMPLE MIXTURES vs COMPOUND MIXTURES

  • Simple mixtures contain only ingredients soluble in the vehicle or present as colloidal dispersions.

• General method of preparation (calibrated dispensing flat method)

  • Stepwise approach: calibrate container, dissolve solids, add triturates, add liquids, rinse, bring to final volume, filter if needed, label.

• Method: Calibrated dispensing flat (illustrative steps)
  1) Calibrate a dispensing flat with appropriate liquid (generally tap water) and rinse with purified water for aqueous solutions.
  2) Assess solubility; add sufficient primary solvent (usually vehicle) to the calibrated container for dissolution of solids.
  3) Weigh the first solid; add to solvent; dissolve (via cap and shake) and repeat for all solids.
  4) Triturates can be prepared separately and added as aliquots to final container.
  5) Measure/add liquid ingredients; cap and shake gently to mix.
  6) Rinse with some solvent or mixture; transfer to final container and rinse mortars; make to final volume.
  7) If necessary, filter through cotton wool; collect filtrate in final container.
  8) Remove calibration mark.
  9) Label appropriately.

• Alternative method: conical measure

  • Steps 1–7 mirror the flat method with measurements in a conical measure; ensure stirring and final volume handling.

• Considerations:

  • Alcohol-soluble medicaments may dissolve more rapidly in a spirit, tincture, or concentrated water as part of formulation.

  • Water-soluble substances may not dissolve well in viscous aqueous media (e.g., syrup) as they would in water.

  • Ensure sufficient solvent to permit rapid dissolution of solids.

• Container and labeling:

  • Use a dispensing flat of appropriate volume; clear bottles preferred unless an amber bottle is recommended for light protection.

  • Official formulary name should be used when appropriate; otherwise label as "The Mixture" followed by ingredients.

  • Do not label with "SHAKE THE BOTTLE" for mixtures (not appropriate here).

• Expiry:

  • Generally, mixtures have an expiry of $28\ ext{days}$ from the date of manufacture, unless otherwise specified.

Grading rubrics

• A rubric explicitly defines assessment criteria and expected performance standards; enables consistent marking and student self-assessment during tasks.

• Benefits:

  • Aids transparency for students (what is expected).

  • Supports consistent marking across assessors.

• Source reference: UNSW assessment rubrics page (link provided in notes).

Grading Rubrics: Specifics and structure

• Structure:

  • Three grading metrics

  • General Grading Criteria Guidelines

  • Grading Criteria Guidelines for Specific Dosage Forms

  • Grading Criteria for Documentation of Specific Dosage Forms

• Marking scale for products:

  • Satisfactory and professional (S/P): everything correct

  • Satisfactory but unprofessional (S/UP): acceptable standard but some aspects could be improved

  • Unsatisfactory (U): product does not meet expected standards

• Overall grade rule:

  • The overall grade for a product is determined by the lowest grade for any criterion (e.g., if patient name is wrong, the product is marked U according to the rubric)

• Availability: all rubrics available through Canvas

General Grading Criteria (selected highlights)

• Descriptors:

  • Correct formula and correct ingredients used; correct quantities used

  • Documentation completeness; correct units; manufacturer, batch number, expiry date; working out/calculations shown

  • Appropriate methods; each step of ingredients and methods checked off; QA declaration signed; self/peer assessment checklist completed

• Common errors flagged in rubric (illustrative examples):

  • Incorrect units (e.g., using a lowercase 'ml' instead of uppercase 'mL') → U or S/UP depending on severity

  • Omitted ingredients or discrepancies between ingredients list and method → U

  • Not checked off or not signed → U or S/UP

  • Incorrect/incomplete patient or prescriber details, dates, or expiry details → U

  • Naming conventions: patient name, prescriber name, date, unique reference number must be correct; if missing or incorrect → U or S/UP

  • Instructions wording: e.g., using "Give" for oral dosage forms instead of "Take"; inconsistent verb choice → S/UP or U

• Common labelling and documentation issues:

  • Not using the official formulary name where appropriate; mislabeling or omission of ancillary instructions; inappropriate or omitted auxiliary labels → U or S/UP

  • Correct container type, size, and calibration marks; no leaks or damages; no contamination; correct color/clarity; good dosage form integrity → S/P or S/UP

Grading Criteria for Specific Dosage Forms

• Liquids (e.g., mixtures, compound mixtures, etc.)

  • Grinding of tablets; final container free of residue; correct route; proper labeling and expiry

• Semisolids

  • Uniform semisolids; final container clean; outside rim clean; proper mixing and suspension quality; proper labeling

• Capsules

  • Capsules should be locked; clean of residue; may include cotton inside; correct route; proper label for administration

• Instillation/Drops

  • Drops application; proper dropper function; container clean; correct verb on directions; correct route and dose

• Suppositories

  • Correct route; uniform and neatly wrapped; ends aligned; smooth surface; final container clean; avoid blocking/obstruction during administration; verb selection (instill) and route (per rectum)

• Additional items

  • Ensure correct instruction verb usage (e.g., "Instill" vs "Administer" vs "Take"), and that dosage, frequency, and duration are expressed clearly

  • Avoid incorrect or ambiguous phrasing; ensure correct patient instructions and safety warnings are present

Grading Criteria for Documentation of Specific Dosage Forms

• General criteria (across dosage forms)

  • Final container type and size; correct measuring devices; method appropriate for product type

  • Crystalline solids: use of glass mortar; final quantity accurately supplied; correct labeling of preservatives where applicable

  • Inaccuracies or omissions in final quantities lead to U; appropriate S/P/S/UP depending on accuracy and completeness

• Liquids (calibration and rinsing)

  • Calibrated to correct amount; rinsed with appropriate liquid after calibration

  • Simple mixtures prepared in conical measure or final container; use of validated apparatus

• Simple mixtures

  • Correct dissolving/mixing solids; appropriate use of tablets/capsules or mortar; preservative usage (e.g., Ethanol 90% as vehicle where applicable)

  • Filtration step as needed; proper filtration medium (gauze or cotton wool)

• Semisolids

  • Control of excess amount; oily vs aqueous phases; proper incorporation of active ingredients; appropriate use of stabilizers like coal tar solutions (where relevant)

• Capsules

  • Correct dosing of active ingredients; appropriate packaging; removal of capsules or opening only when permitted; avoid contamination with sites and cross-contamination risks

• Suppositories (documentation) and dermal/neosystems

  • Properly documented processes for molding, lubrication, and packaging; correct dosage calculation and storage conditions

• Preservatives and vehicles

  • Preservative usage documented; ethanol usage guidelines followed; correct vehicle for the dosage form; rinsing and cleaning steps appropriately documented

• Labeling and auxiliary labeling

  • Correct labeling conventions; auxiliary labels present and complete; patient safety prompts included (e.g., "Shake well", storage conditions, "Keep out of reach of children" where applicable)

Practical implications and real-world relevance

• APF26 and the Dispensing Manual together provide the clinical and technical foundation for:

  • Safe and accurate compounding in education and future practice

  • Consistent labeling, storage, and expiry practices to protect patient safety

  • Understanding of how to prepare liquids, mixtures, and dosage forms with proper documentation

  • Framework for evaluating student work through explicit rubrics and criteria

• Ethical/clinical considerations

  • Appropriate cautions and advisory labels to minimize risk and ensure informed use

  • Awareness of drug-specific hazards (e.g., spironolactone formulations and handling precautions)

  • Rationale for expiring dates and storage requirements to preserve potency and safety

• Real-world relevance

  • The need to stay current with the latest APF edition to align practice with contemporary standards

  • Training in how to translate APF guidance into lab practice, dispensing workflows, and patient communications

Quick reference: key numerical values and constants mentioned

• Storage for spironolactone mixture CF: $2-8^{\circ}\mathrm{C}$

• Expiry for spironolactone mixture CF: $90\ ext{days}$ from date of preparation

• Storage for spironolactone suspension (25 mg/mL formulation): $<25^{\circ}\mathrm{C}$ (below 25 °C)

• Expiry for spironolactone suspension: $60\ ext{days}$ from date of preparation

• Expiry for general mixtures: $28\ ext{days}$ from date of manufacture (unless otherwise specified)

• Common volumes for formulations:

  • Final volume examples include $100\ ext{mL}$ for a suspension; usage of calibrated measuring devices in steps; volumes like $50\ ext{mL}$ to $100\ ext{mL}$ present in the formulation steps

• Example reference points in APF/Table pages (e.g., Table 2.3, Table 2.6, Table A2, p. 19) referenced for labeling and abbreviations

If you want, I can reformat these notes into a printable study sheet or extract only the sections most likely to be tested for your upcoming exam. Also, tell me if you’d like a concise one-page summary or a more detailed, multi-page version.