Routine for compassionate use, named patient in hospitals

When ordering unregistered medicinal products for departmental use (not related to individual patients), "consent must be obtained from the responsible senior medical consultant of the respective department" in accordance with the Medicinal Products Regulation § 2-5. 

E-prescriptions cannot be used for ordering for departments. Some health trusts are planning solutions where applications for compassionate use, named patient will be integrated into an electronic prescription system, but this is likely to take some time. 

Until such solutions are in place, NOMA offers a simplified routine for applications for compassionate use, named patient for medicinal products used in hospital departments. This routine requires cooperation between the hospital department and the hospital pharmacy. 

For Notified Products:

1. The hospital pharmacy prepares an annual overview (list) of the unregistered medicinal products delivered to the department in the last year: ATC code, active ingredient, product name, strength, form, and quantity. If desired, other information such as price can be included. 
2. The senior medical consultant of the department reviews the list and evaluates the use of unregistered medicinal products. If there are products that will not be used in the department in the coming year, they are removed from the list.
3. The senior medical consultant signs the updated list and returns it to the hospital pharmacy. The signature confirms that the senior medical consultant has evaluated the use of the listed unregistered medicinal products and that their use is medically justified.
4. The hospital pharmacy retains the signed lists at the pharmacy for one year

For Products Requiring Pre-Approval from NOMA Before Dispensing: 

A signed paper application is scanned and sent as a PDF file to the following email address: godkjenningsfritak@dmp.no. NOMA processes the application and responds via email. Submission by post is still possible but will extend the processing time. 

If the application concerns an individual patient to be treated in a hospital department, the application should not include any personal information other than initials and age. 

Paper applications from hospital departments sent as a PDF file via email will have the same validity as paper applications sent by post.