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DSL-021 Risk Analysis of Medicines Produced in Hospital Pharmacy – a Tool For Ensuring Optimal Supply
  1. L Schmidt-Petersen,
  2. L Jensen,
  3. C Dinsen-Andersen
  1. The Capital Region Hospital Pharmacy, Medicine Information, Copenhagen, Denmark


Background The hospital pharmacy unit for the preparation of licenced sterile medicines manufactures 110 different extemporaneous preparations and licenced medicines for injection or infusion. This unit needs a tool for production planning i.e. an assessment of which medicines are critical and hence must always be in stock.

Purpose To create a tool for risk assessments for all medicines manufactured in the unit, enabling appropriate prioritising of resources from a treatment perspective.

Materials and Methods All risk assessments are executed and stored in SAID (National question and answer database). The advantages of this method are that each risk assessment is quality assured and acts as a dynamic document that can be updated regularly.

Risk assessments are based on relevant literature (e.g. Summary of Product Characteristics and Micromedex).

For each risk assessment the following is examined as a minimum:

  • Which patient group will benefit from the medicine?

  • Therapeutic indications and administration

  • Are there any alternative treatments?

  • Does a synonymous/analogous medicine exist? Any safety concerns regarding method of administration? Can the manufacturers maintain the flow of supply?

Based on the above the risk assessments are allocated a score 1 to 5, which indicates the severity of a back order.

Results The risk assessments were distributed as follows:

  • 18% scored 5 (no alternative medicine exists)

  • 38% scored 4 (analogous medicine exists)

  • 24% scored 3 (synonymous extemporaneous or non-licenced medicine exists)

  • 9% scored 2 (synonymous medicine exists)

  • 11% scored 1 (more than one analogue/synonym exists)

The risk assessments showed that none of the medicines could be dispensed from a treatment perspective. Shorter periods of back order of some medicines can be tolerated with no effect of patient care and safety, if alternative synonyms/analogous medicines are supplied from other manufacturers.

Conclusions Risk assessments have given the unit a tool for production planning and prioritising the manufacturing of medicines.

No conflict of interest.

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