Medicine Formulations 1 wk1

week 1

What are the Australian compounding regulations and standards of practice?

Pharmacy Board of Australia guidelines, PSA standards, QCPP, Advanced Pharmacy Australia standards, VPA guidelines, USP chapters, PIC/S GMP guides, and Safe Work Australia regulations1

What are the Pharmacy Board’s expectations of pharmacists in relation to compounding medicines?

Competence in simple compounding, CPD requirements, and regular validation for complex compounding

How can pharmacists apply relevant regulations in compounding medicines?

By conducting risk assessments, ensuring QA and QC, maintaining proper documentation, and adhering to packaging and labelling requirements1.

What key aspects should be considered when formulating compounded medicines?

Refer to reputable references, document risk assessments if no formulation precedent exists, justify decisions with evidence, ensure appropriate quantity, and consider stability/expiry.

What information should pharmacists provide regarding ingredients in compounded medicines?

Provide transparent information about all ingredients, avoid 'secret' ingredients, and alert patients to any formulation differences, particularly for high-risk medicines.

What documentation is required for compounding medicines?

Documentation should justify the decision to compound, support quality assurance, account for controlled ingredients, enable recalls, support adverse event reporting, and be easily retrievable

What aspects of premises and facilities are important for compounding?

Ensure the premises are adequately designed, equipped, maintained, resourced, and staffed.

What should pharmacists do regarding ingredient sourcing?

Source ingredients from manufacturers with approved QA/QC procedures. Confirm the manufacturer has an appropriate license, certificate, or accreditation. Ingredients must be pharmaceutical grade with a certificate of analysis.

What are the key areas to consider during risk assessment?

atient-related, formulation-related, personnel-related, premises-related, and regulation-related risks

What are the responsibilities of a supervising pharmacist?

Ensure staff education/training, assign duties based on experience, manage risks, verify weighing/measuring accuracy, ensure proper packaging/labelling, follow reputable formulas, document procedures, approve supply, and counsel patients.

What equipment is used to measure mass in compounding?

Top-pan balance and analytical balance.

What equipment is used to measure volume in compounding?

Beaker, measuring cylinder or graduated cylinder, conical measure, and pipette.

What materials are mortars made from, and when should each be used?

Ceramic mortars are used for powder grinding and sticky preparations. Glass mortars are used for soft aggregates with large amounts of liquids because they are nonstaining and nonporous.

What is trituration?

The process of grinding powders to reduce particle size.

What is levigation?

The process of reducing particle size of a solid by triturating it in a mortar with a small amount of liquid.

What is geometric dilution?

A technique used to ensure uniform mixing of two or more powders, where the smaller quantity of powder is mixed with an equal volume of the larger quantity, and the process is repeated until all powders are combined

Why is documentation important in compounding?

Documentation is part of quality assurance, enables tracking of ingredients/processes/responsibilities, and ensures clear, comprehensive, and legible records.

How long should compounding records be kept? What do they include?

Records must be kept for 3 years and include SOPs, risk assessments, compounding record forms, and quality control records.

How does compounding differ from manufacturing?

Manufacturing is a commercial activity involving production, processing, and distribution for general/wholesale supply, while compounding is for a specific patient's needs.

Define "simple" compounding.

Preparation and supply of a single 'unit of issue' for a specific patient, often using published formulations like the APF.

Define "complex" compounding.

Requires special competencies, equipment, processes, and/or facilities (e.g., sterile preparations, hormones, cytotoxic preparations).

When can pharmacists compound medicines?

When a suitable commercial product doesn't exist or can't be accessed in time, if a commercial medicine is not suitable for the patient, or for research purposes with REC approval.

When is a clinical justification needed for compounding?

A risk assessment, including a clinical justification, MUST be completed for each request for a compounded medicine.

What factors should be considered before compounding?

Availability of commercial medicine, suitability of the compounding environment, evidence to support compounding, patient safety, and patient consent.

What steps should be taken when a medicine cannot be compounded?

Notify the patient and prescriber, offer to discuss other options, and refer to the Code of Conduct on providing good care.

What is the role of the Drug and Therapeutics Committee in a hospital setting regarding compounded medicines?

They determine if a medicine is appropriate for compounding in anticipation of being needed to treat a patient.

hat requirements must manufacturers of therapeutic goods meet according to the Therapeutic Goods Act 1989?

They must hold a license (or a conformity assessment certificate).

Are compounded medicines required to be entered on the Australian Register of Therapeutic Goods (ARTG)?

No, with the exception of medicines used for gene therapy, medicinal cannabis products, or products that contain GLP-1 receptor agonist analogues.

What does 'single unit of issue' mean in the context of compounding?

It's the quantity that the patient requires for the treatment period determined by the prescriber and that meets the required quality standards for the duration of the treatment period.

What considerations must be made regarding patient safety when deciding to compound a medicine?

Safety, quality, and efficacy must be supported by reputable references. Patient consent to receiving a compounded medicine must also be obtained, and the Code of Conduct regarding informed consent should be followed.