Romano A Fois
Barry T Mewes
Interest by prescribers and pharmacists in the provision
of individualised pharmaceutical therapy in the form of
compounded medicines has grown in recent times. However,
there have also been a number of case reports of patient harm
associated with these medicines.
To highlight areas for clinicians and pharmacists to consider
when prescribing or dispensing compounded medicines, which
are consistent with quality use of medicines principles.
Regulators of pharmaceutical products have expressed
concerns with the production, marketing and use of
compounded medicines dispensed by pharmacists. This has
prompted debate over the need for more regulation of these
products. We propose an expansion of off label prescribing
guidelines to include a risk based assessment of pharmaceutical
quality, a consumer information/education strategy and the
development of a code of practice for pharmacists engaging
in compounding. These strategies recognise a shared
responsibility among prescribers, dispensers and regulators to
achieve contemporary quality, safety, and efficacy standards
and support the quality use of compounded medicines.
There has been a recent rise in the prescribing and dispensing of compounded medicines both in Australia and overseas. These activities are proposed to offer benefits by individualising pharmaceutical therapy to patients’ needs. However, case reports of patients coming to harm following the use of compounded medicines and the absence of regulated processes for evaluating these medicines for quality, safety and efficacy, warrant a review of the activities and responsibilities of prescribers, pharmacists and regulators concerning compounded medicines.
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