From "Managing Director"
SIR,-As the managing director of a necessarily anonymous specials manufacturer, perhaps I may be allowed to comment on Mr Patel's letter on remuneration for extemporaneous preparation (PJ, May 6, p692), which also links indirectly to the recent debate on professional competence to compound individual patient medication.
While I would not for a moment wish to see further restrictions on the professional role of pharmacists, it is generally the case that extemporaneous compounding is more closely regulated in hospital pharmacy departments than it is in community pharmacy. The level of control expected by the Medicines Control Agency within licensed specials manufacturers is correspondingly higher again than that found in most hospital dispensaries. Typically, a manufacturer would be expected to produce non-sterile items in Class 10,000 (or better) cleanrooms, quality control all components and ingredients (including water), maintain validation and calibration of all processes and equipment, training records for all staff, environmental monitoring data for all facilities, stability data for products and, most importantly, produce (and archive) full documentation on all aspects of the preparation of each individual item.
This level of control and documentation goes some way to explaining the quoted cost from BCM for this relatively simple product, potassium permanganate solution. However, had Mr Patel contacted our company to obtain his "market value", he would have been quoted (for next day delivery of a quality-guaranteed product) less than 25 per cent of the figure mentioned in his letter. In summary, therefore, we currently have an extremely unlevel playing field in terms of enforceable standards, serious implications for community pharmacists in terms of civil or even criminal liability, if they compound defective products and wildly different costs for various mechanisms or sources of medicines supply. All things considered, one can understand why the Society's Council, and perhaps even the Department of Health, see this apparently harmless remnant of the pharmacist's "traditional" role as something of a hot potato.
Managing Director
(297/19)