Pharmacotherapeutic rationale of pharmacy drug compounding: Evaluation and applicability of the guideline from the Laboratory of Dutch Pharmacists (LNA)

Objective: Recently the Laboratory of Dutch Pharmacists (LNA) published a guideline (LNA-procedure P01-2) to assess the pharmacotherapeutic rationale of pharmacy-compounded products. We evaluated this procedure and we investigated the rationale of a representative part of standardised products compounded in our hospital pharmacy. GMP requirements increase the cost of compounding. As a consequence, although every patient should have access to high-quality pharmacy-compounded products through his own pharmacist, it is not feasible to operate a compounding activity in each community pharmacy. Although pharmacy-to-pharmacy distribution of compounded products is forbidden within Dutch law, the Healthcare Inspectorate accepts this if three additional requirements are met. One of these requirements is a product file containing the documented pharmacotherapeutic rationale of the compounded product. Design and methods: LNA-procedure P01-2 was evaluated and adjusted. The primary criteria were simplified and the secondary criteria were reduced from 5 to 2 without loss of information. The adjusted procedure was used to review the rationale of the selected products. Results: 34 products with 36 indications were reviewed. All products except one were classified as effective and safe. For 16 products there was no registered equivalent available in the Netherlands. 14 products had a specific advantage over registered products, for example formulations for children. Conclusion: The LNA guideline procedure to standardise assessment of the pharmacotherapeutic rationale of pharmacy-compounded products is, with a few adjustments, suitable in daily practice. The added value of pharmacy-compounded products is partially based on the lack of registered products and partially on dosage forms that are better attuned to their intended use.