Specials manufacturing

Created by: SamDavies
Created on: 15-05-19 17:36

What is a pharmaceutical special?

Products which are prescribed for individuals which are unlicensed

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In which cases do patients require medicines which do not have a license?

Pt may be allergic to an additive, require a stronger or weaker form, different dosage form or presentation

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What license is required by the supplier who manufactures the special to showcase their facilities have reached a minimum standard?

Specials manufacturing license

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Who takes full responsibility for any adverse effects caused by an unlicensed pharmaceutical special (unless it can be demonstrated that the medicine was faulty)?

Prescriber

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Which certificate should accompany any specials product supplied?

Certificate of analysis

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Are pharmaceutical specials assessed by a licensing authority for safety, quality and efficacy?

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What is the risk of sourcing pharmaceutical specials from a variety of manufacturers?

Variability in formulation, excipients, bioavailability and efficacy

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How to determine the need for a pharmaceutical special?

Review need for current medication, some specials have been superseded by commercially available licensed products, some solid dose allow for 'sprinkling' on food, consider alternatives such as licensed dispersible formulations

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Do requests to prescribe unlicensed pharmaceutical specials by a third party, like secondary care, diminish the responsibility of the prescriber?

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Other cards in this set

Card 2

Front

In which cases do patients require medicines which do not have a license?

Back

Pt may be allergic to an additive, require a stronger or weaker form, different dosage form or presentation

Card 3

Front

What license is required by the supplier who manufactures the special to showcase their facilities have reached a minimum standard?

Back

Card 4

Front

Who takes full responsibility for any adverse effects caused by an unlicensed pharmaceutical special (unless it can be demonstrated that the medicine was faulty)?

Back

Card 5

Front

Which certificate should accompany any specials product supplied?

Back

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Specials manufacturing