Extemporaneous Dispensing Flashcards
Extemporaneous dispensing must be:
safe, efficacious and consistently high quality.
Are Extemporaneous compounds on the ARTG?
Now compounded or extemporaneous products are not listed on the ARTG nor are they required to be listed on the ARTG.
Because they are being made up for a person to use, as a single use, to meet a therapeutic need they are not on the ARTG.
Compounding for Animals is regulated by:
(Australian Pesticides and Veterinary Medicines Authority) APVMA. A compounded product for the treatment of an animal (including a non-prescription product) is exempt from registration by the APVMA if it is prepared on the instruction (preferably written) of a veterinary surgeon for a particular animal patient. Pharmacist who compound for animals must have special training to do so.
Complex compounding
Complex refers to compounding that requires special facilities, equipment or conditions. Also includes compounding that involves ingredients that might pose a bio hazard ie cytotoxic, hormone ingredients, require sterile conditions, or are modified release ingredients.
Professional Obligations : PPS 5?
PPS 5 requires pharmacists to be suitably trained, possess the competencies and skills required in compounding techniques. The premises, raw materials and equipment must be at an acceptable standard for compounding purposes.
Compounded dosage forms that must be sterile when administered to patients include (but are not limited to) those that are:
- administered by injection
- intended for ophthalmic use
- intended for irrigation use
- intended for intra-urethral use
- intended for use as an implant
- intended for use on open wounds or severely damaged skin (e.g. burns)
- intended for otic use after surgery (other otic preparations are also often supplied sterile)
- liquid inhalants that are intended for nebulisation peritoneal dialysis solutions.
PRODUCT NEED
Pharmacists should consider whether there is an available commercial product entered in the ARTG that would have a similar therapeutic effect and could be safely used for the intended purpose instead of an extemporaneously prepared product.
Generally, it is only appropriate to prepare an extemporaneous product if the pharmacist has established that there are no suitable commercially available products or therapeutic alternatives.
CATEGORIES OF RISK ASSESSMENT
- premises related-consider quality assurance systems, suitability and sensitivity of equipment, sterile environment, environmental conditions, storage, maintenance and calibration of equipment
- product related-consider dosage form, complexity of the formulation, stability, need for sterile preparation, quality and availability of ingredients, expiry dates, batch preparation, potency of active substances, pharmacological effect, narrow therapeutic index
- personnel related-consider level of training and experience, compliance with professional standards, use of personal protective equipment for hazardous ingredients
- patient related-consider age, weight, comorbidities, altered pharmacodynamics or pharmacokinetics, current medicines. Making any changes to an existing Australian Pharmaceutical Formulary or pharmacopoeia I formula (e.g. by adding, changing or excluding ingredients) will result in a non-pharmacopoeia! formula.
Describe appropriate circumstances for compounding medicines.
Circumstances in which compounding is appropriate is:
• If there is a therapeutic need and there is no existing formulation ARTG formulation that would give similar and about the same therapeutic outcome or effect
• If commercial product is unsuitable (ie allergy to an excipient)
• For research purposes
SIMPLE COMPOUNDING
Simple compounding may routinely involve compounding products:
• from formulations published in reputable references such as the Australian Pharmaceutical Formulary and Handbook, excluding the preparation of sterile products from these formulations which is considered complex compounding, or
• using other formulations for which information confirming quality, stability, safety, efficacy and rationality is available (like in the APF)
Does a pharmacist need TGA license to compound?
A licence from the TGA is not required when a
pharmacist is:
i. Practising:
• in a pharmacy which is open to the public, or
• on the premises of a private hospital.
(Note: supply must be on or from those premises,
and must not be by wholesale).
OR
ii. Employed in public hospitals or public
institutions, and medicines are manufactured for
supply in public hospitals or p
Discuss the necessary formulation considerations when compounding medicines.
When compounding medicines, pharmacists must ensure that there is good clinical and pharmaceutical evidence to support the quality, stability (including appropriate expiry periods), safety, efficacy and rationality of any extemporaneous formulation. This may involve collaboration with the prescriber, so an agreement on the suitability of the product for the intended patient is able to be achieved.
At all times the pharmacist must be satisfied that the dispensing and supply of a compounded medicine is consistent with the safety of the patient (refer to Guideline 1 Dispensing precaution – safety of prescriptions of the Board’s Guidelines for dispensing of medicines).
This includes off-licence use of medicines which are to be compounded into a product. Consideration should also be given to whether a compounded medicine is appropriate for use, for example a sports supplement (refer to the section Drugs in sport in the current edition of the Australian Pharmaceutical Formulary and Handbook).
Evidence to support a decision to compound a medicine must be obtained from reputable references (refer to the reference texts for compounding pharmacists listed in these guidelines), international pharmacopoeial standards, or peer reviewed journals, and must not be based on testimonials and impressions
Exempt Persons
Pharmacists are considered ‘exempt persons’ in relation to “the manufacture of therapeutic goods” as seen in the excerpt below from the Therapeutics Goods Regulation 1990 (Cwlth).
EXEMPT GOODS
Exempt Goods
Are those goods that, while being captured by the definition of “therapeutic goods” in the Therapeutic Goods Act 1989, are not required to be entered in the ARTG.
As stated above, “exempt goods” include medicines dispensed or extemporaneously compounded for a particular person for therapeutic application to that person.
