Statement 3.1

“Before pharmacy manufacture or preparation of a medicine, the hospital pharmacist should ascertain whether there is a suitable commercially available pharmaceutical equivalent, and if necessary, discuss the rationale for this decision with the relevant stakeholders.”

What does it mean for patients? Individual preparations can improve the outcome of patients. If there is a perceived benefit for a particular patient/patient group, a discussion between the prescriber and the pharmacy should take place, especially if there is a commercially available suitable pharmaceutical equivalent.

All patients should be informed about the risk/benefit assessment for their treatment.

What does it mean for healthcare professionals? The decision on whether an individual preparation may improve the patient’s outcome is a complex one and doctors and pharmacists should therefore make a joint assessment of the risk/benefit balance considering all aspects (therapeutic, pharmaceutical, environmental and personal).

The professionals involved in patient care should jointly assume responsibility in this assessment for determining the added value of a pharmacy preparation.

What does it mean for Hospital Pharmacists? Pharmacy preparations are not advisable if a suitable pharmaceutical equivalent with a marketing authorisation is available. Before preparation the pharmacist should verify whether a pharmaceutical equivalent is available, taking into account pharmaceutical form and the strength.

Hospital pharmacists should develop together with doctors and other healthcare professionals’ criteria for the risk/benefit assessment.

These criteria may consider:

• The individual situation of the 
patient
• The availability of a validated 
formula
• The availability of ingredients of 
pharmaceutical quality
• The equipment necessary for 
safe preparation (e.g. clean 
rooms)
• The experience and skill of 
personnel