E-DRUG: Pharmaceutical Compounding and Access to Medicines (5)
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The Australian Pharmaceutical Formulary was first produced in 1902 and from the beginning included formulae for standard compounded medicines along with instructions for preparation.
The APF was closely linked to the formulae and standards of the British Pharmacopoeia.
Recent editions are called the Australian Pharmaceutical Formulary and Handbook and many guidelines and standards are included as well as formulae and instructions for compounding medicines.
This is what the APF and Handbook says about extemporaneous dispensing (compounding).
QUOTE
Extemporaneous preparations for individual patients can be manufactured by pharmacists in premises which are not accredited under the Code of Good Manufacturing Practice (CGMP) requirements. However, pharmacists have a duty of care to ensure manufactured products are safe and efficacious. The use of sound pharmaceutical techniques is essential to ensure that a product of adequate quality is produced.
Extemporaneous dispensing (compounding) is the preparation and supply of a single unit of issue of product which is intended for immediate use by a specific patient. Extemporaneous manufacturing, which is the production of a batch of a product resulting in a number of units of use intended for supply over a period of time, is strongly discouraged unless performed in premises approved for such purposes and the product has documented stability data. Pharmacists who undertake extemporaneous manufacturing have an obligation to be aware of, and comply with, CGMP requirements.
Pharmacists should not compound preparations for which they do not have the appropriate facilities or equipment and/or for which they do not possess the relevant contemporary experience and expertise.
The designation of CF (Children's Formula) is used to identify a formulation that is intended for use in children. The designation BP refers to the current edition of the British Pharmacopoeia.
Many drugs are not formulated commercially in dosage forms suitable for paediatric use. In these cases it may be necessary to prepare liquid oral formulations using commercially available products including injections or tablets/ capsules. In these exceptional cases, consideration must be given to stability of the drug in the vehicle. Pharmacists are advised to contact a hospital pharmacy department for advice.
- When using tablets or capsules, the highest strength available should be used wherever possible to minimise the amount of other ingredients.
- Sustained-release or enteric-coated products should not be used.
- If tablets are used, they should be crushed and the powder triturated with a small amount of the vehicle before making to volume.
In these types of preparations suspending agents may be required (refer to section on mixtures) .
Formulations in the Australian Pharmaceutical Formulary and Handbook are intended primarily for extemporaneous dispensing by pharmacists. When a product is required to be freshly prepared, it should be issued within 24 hours of preparation. When a product is required to be recently prepared, it indicates that deterioration is likely if the product is stored for longer than four weeks. It is therefore desirable for the product to be issued within seven days of preparation.
An expiry date of 28 days from the date of manufacture should apply to all such products. In general, unless otherwise specified, an expiry date of 28 days from the date of opening should apply to all other extemporaneously prepared formulations.
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The APF and Handbook provides specifications that cover equipment, premises, quality of raw materials, use of aseptic technique, sterilization and training for all aspects along with tests for sterility and quality.
Standardised storage instructions and labeling standards which have been adopted in Australia are specified. Documentation is recommended for all extemporaneous dispensing to enable the full history of a product to be determined.
If anyone is interested to see the full section I can send it directly.
Beverley Snell - E-Drug Moderator
Australia
email <bev@burnet.edu.au>