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
Lecturer (Pharmaceutics)
Andrew J McLachlan
Professor of Pharmacy (Aged Care)
Barry T Mewes
Visiting Pharmacist
Iqbal Ramzan
Professor of Pharmacy and Dean
Faculty of Pharmacy
University of Sydney
| Table 1 |
| A risk-based evaluation of compounded medicines |
| Factors | Risk criteria |
|
| Patient population | Is the medicine to be used in a high-risk population (e.g. children, the frail elderly)? |
| Site of action | Is the medicine intended to have a local or systemic effect? |
| Indication | Does the indication require acute or chronic therapy? |
| Route of administration | Is the medicine intended for topical, enteral or parenteral administration? |
| Pharmacodynamics | Is there a wide or narrow safety margin (therapeutic index)? Is the dose-response relationship steep or shallow? |
| Biopharmaceutics | Do formulation factors affect the bioavailability or stability of the medicine? Is the bioavailability highly variable? Is the complexity of the formulation appropriate for a compounded medicine and is dose-uniformity guaranteed (e.g. in sustained release, transdermal or inhaled formulations)? Is quality-assurance testing required and can it be performed? |
| Regulatory | Are the active and inactive ingredients approved for use in Australia? Have any of the ingredients been withdrawn or rejected from registration because of safety concerns? |
