Extemporaneous preparation prescription assessment

Prescriptions for extemporaneous preparations are assessed for formulation, dose, clinical and economic benefit. 

When a pharmacist is to prepare an extemporaneous preparation for which no standard formulation exists, there is usually not much time for experiments and pilot batches. The risk assessment of the prescription should however be performed carefully (see Sect. 2.2). The preparation process should be validated on the level of dosage form and the preparation documentation (see Sect. 33.5), including the results of in-process controls, should be evaluated by the pharmacist before dispensing for use by the patient. 

Section 2.2.3. depicts models for a stmctured risk assessment of a prescription for extemporaneous preparations. The physician and the patient will be the most important stakeholders in that situation, the latter also represented by the competent authority. But the insurance company may be stakeholder as well because of the resources. 

Of course these topics should be discussed in relation to the scale of the preparation and other items that affect the risk assessment. Commonly the product file for a non-standardised extemporaneous preparation, may consist of only a prescription assessment and a preparation record, possibly with a cover sheet for archiving the other sections may remain unfilled. If available, referral can be made to a general file for the appropriate dosage form. 

A PQS for pharmacy preparation moreover needs the element of controlling and documenting the therapeutic aspects, as well as the prescription assessment in case of extemporaneous preparation for licensed medicines this part is separately regulated in the registration process. 

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See also in sourсe #XX -- [ ]

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