Statement 3.5

  • Section 3

“Hazardous medicines should be prepared under appropriate conditions to minimise the risk of contaminating the product and exposing hospital personnel, patients and the environment to harm"

What does it mean for patients? To avoid harm to patients, medicines must be produced using high quality ingredients. National and internationally validated methods should be used in the pharmacy in order to guarantee the quality of the starting materials and as a consequence the final product.

What does it mean for healthcare professionals? Healthcare professionals should be aware of the quality of the products prepared by the pharmacy.
To assure that all starting materials and as consequence the final product have high quality hospital pharmacists should use national and international validated methods (pharmacopeia and similar standards).

What does it mean for Hospital Pharmacists? All ingredients used in preparations should be analysed using national and internationally validated methods (pharmacopeia and similar standards). Certificates of external providers should also fulfil the requirements of such standards. The risk assessment should consider the contribution of active pharmaceutical ingredients and excipients to the safety profile of the pharmacy preparation.

Where appropriate, active pharmaceutical ingredients manufactured according to best practice and analysed according to pharmacopoeial standards should be used.

The chemical, pharmaceutical and microbiological quality of the starting materials should be fit for pharmaceutical use and be demonstrated on the basis of validated methods. 

The Hospital Universitario Clinico San Carlos is SILCC Host providing training on this Statement. Please learn more about the SILCC programme here.