QC Tutorial

Created by: LBCW0502
Created on: 22-11-18 18:20

What is a device recall?

Manufacturers remove products from the market or correct products which present a risk of injury. This action protects public health and wellbeing

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How should you respond as a pharmacist to a defective product?

Manufacturers provide alerts about defective medicines (MHRA website). Isolated incident (treat incident e.g. side effects). Multiple incidents (test device for defect, report to MHRA, medicines management team). Contact patients about device recall

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Describe features of class 1 drug/device recalls

Requires immediate recall, product poses serious or life threatening risk to health

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Describe features of class 2 drug/device recalls

Specifies a recall within 48 hours, defect could harm patient but is not life threatening

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Describe features of class 3 drug/device recalls

Requires action to be taken within 5 days, defect likely to harm patients and is being carried out for reasons other than patient safety

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Describe features of class 4 drug/device recalls

Advise caution to be exercised when using product, but indicate that the product poses no threat to patient safety

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Which class are most recalls within?

Classes 2 or 3

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Give examples of recent drug/device recalls

Lumiracoxib to treat OA was withdrawn due to serious liver toxicity. Insulin pens led to risk of hyperglycaemia due to cartridge holder weakening when exposed to household chemicals etc.

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What is a drug recall?

Remove prescription or OTC drug from market by MHRA or EMA

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What would be the reasons for a drug recall?

Causes injury, faulty, poor quality, counterfeit etc.

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Other cards in this set

Card 2

Front

How should you respond as a pharmacist to a defective product?

Back

Card 3

Front

Describe features of class 1 drug/device recalls

Back

Card 4

Front

Describe features of class 2 drug/device recalls

Back

Card 5

Front

Describe features of class 3 drug/device recalls

Back

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QC Tutorial