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Letter to the Editor
Editor, The editorial 'Compounding in community pharmacy' (Aust Prescr 2008;31:30-1) outlines concerns that regulators have with the activities of some 'compounding' pharmacists. Regulators are concerned with high-volume (bulk) compounding and the promotion of formulations that are not subject to the same regulations as are applied to the pharmaceutical industry. They do not appear to be concerned with single-unit extemporaneous dispensing of low-risk products.
While we agree that compounding practice standards are in need of review, we believe a risk-management approach should be followed. Uniform adoption of standards that may, for example, demand end-product testing would not seem practical, or necessary, for low-risk extemporaneously prepared products such as creams or lotions.
The prescribing of many compounded medicines is regarded as 'off label'. Consequently, prescribers and dispensers should be guided by contemporary standards for evaluating off-label prescribing.1We believe the guidance for off-label prescribing should be extended for compounded medicines to include the risk-based evaluation and classification of the factors outlined in Table 1.
We suggest a code of practice in compounding which would include:
- establishing, assuring and maintaining quality through appropriate processes and documentation
- a risk-management approach (Table 1) to the evaluation of compounded medicines
- ensuring that prescribers and consumers have current, evidence-based information to support the quality use of compounded medicines
- complying with therapeutic goods advertising codes and legislation.
These risk-management approaches would support the role of pharmacists in compounding medicines to contemporary standards of quality, safety and efficacy within the spirit of Australia's National Medicines Policy.
Romano A Fois
Andrew J McLachlan
Professor of Pharmacy (Aged Care)
Barry T Mewes
Professor of Pharmacy and Dean
Faculty of Pharmacy
University of Sydney
- Gazarian M, Kelly M, McPhee JR, Graudins LV, Ward RL, Campbell TJ. Off-label use of medicines: consensus recommendations for evaluating appropriateness. Med J Aust 2006;185:544-8.