Guidelines for the introduction of new medications
GINF guidelines. Version 3.0, 2007.
Agency for the Evaluation of Healthcare Technologies of Andalusia: enlace PDF
The GINF guidelines consist of a questionnaire to be filled in by any physician who wishes to request the inclusion of a new drug in the hospital’s formulary.
It comprises four general sections, the most exhaustive of which is dedicated to evidence on the medicine’s efficacy, effectiveness and safety. The guidelines are basically geared toward providing information on the following:
- Indication for which the application is made.
- Evidence on the efficacy and safety of the drug for the said indication, based on clinical trial results.
- Efficacy, safety or efficiency advantages of the drug as compared with the medicines already included for the indication in question.
- Data on the number and characteristics of the patients targeted to be prescribed the new drug.
- Economic data and cost-effectiveness analysis.
The application form model follows a similar methodology to the new technologies procurement form used by Andalusia’s Healthcare Technologies Evaluation Agency.
The criteria employed by the Pharmacy and therapeutics Committee to approve the new drug are included in a section of the application form model. It provides the requesting physician information about the criteria used by the pharmacy committee and ensures that the evidence supporting the introduction of the new drug is presented rigorously and in a systematic way.
Experience in the Virgen del Rocío hospital
Link to PowerPoint presentation