Statement 4.7

Section 4

"Hospital pharmacists should inform, educate and advise patients, carers and other health care professionals when medicines are used outside of their marketing authorisation” 

What does it mean for patients? Medicines are thoroughly tested and regulated before prescribed and given to patients. There may be times they are used in a way for which they are not approved, under the supervision of the doctor. 

Any use of these medicines in this way should be discussed with the hospital pharmacist before prescription and/or administration 

What does it mean for healthcare professionals? Medicines should be used under the conditions of the marketing authorisation for which they are approved. For certain patient groups or indications there may be a rational reason to use a medicine outside of its marketing authorisation (off label use). This decision should be taken in consultation with the pharmacy department who will advise regarding the indications/patient group for which a medicine is licensed for and if it is appropriate to be used in another way for a specific patient/patient group. 

What does it mean for Hospital Pharmacists? Pharmacy departments should proactively inform other healthcare professionals of the approved indications and conditions for approved medicines. Use outside of the marketing authorisation may be justified if there is sufficient evidence to support its use in that way. This decision must be done in collaboration with hospital pharmacists because responsibility and liability may be shared between all staff involved in the process, and they need to be aware of this.