To develop tools and provide information for quality evaluations, and to make them available in a timely manner for use in the selection process of Spanish hospitals.
The collaboration of pharmacy services is intended to increase the efficiency, quality, speed and independence of the drug selection process in hospitals.
The review and selection of medicines is a multidisciplinary and participatory task involving different professionals. Therefore, the methodological tools, the evaluation models and the results of this working group will be made available and disclosed to the extent that they can be applied to the different areas in which the evaluation of medicines is of interest.
A) HOSPITAL OBJECTIVES
Primary objectives:
-Development of a specific methodology to produce evaluation reports by using standardized procedures.
-Validation of this methodology by having group member use it, verifying that it covers the needs of the different types of medicines to be evaluated, that it is reproducible and applicable.
Secondary objectives:
-Disclose the methodology so that it can be applied in different hospitals.
-Establish a system to allow hospitals to participate in drafting the evaluation reports if they so wish.
-Draft reports on new medicines on behalf of the working group for publication on the SEFH website.
-Follow-up programs: Study of the implementation of decisions and programs to monitor the use of medicines.
Research objectives:
-Analyze the process for evaluating and selecting medicines in Spanish hospitals.
B) OBJECTIVES OF OTHER STAKEHOLDERS AND INSTITUTIONS
Government agencies
The GENESIS working group will study and recommend the measures and steps that SEFH management can take on behalf of the society for professionals and institutions who participate in the authorization and marketing of new medicines (evaluation agencies, AEMPS, the Spanish Ministry of Health, the Spanish Health Services of the Autonomous Regions) to maximize the degree of information and transparency necessary to carry out quality technical evaluations.
Scientific societies in other disciplines
The expert groups of scientific societies develop and disclose recommendations on medicines by publishing Clinical Practice Guidelines and through consensus on the use of medicines and how it impacts on the discipline’s practitioners. New medicines and indications are also frequently introduced at scientific activities organized by these societies. Occasionally several of the societies would collaborate on topics of common interest to make joint recommendations. GENESIS will steer the collaboration between the SEFH and other scientific societies in other disciplines in documentation preparation and decision-making processes for the evaluation and selection of medicines as it can offer specific knowledge and criteria outside the promotional environment.
Information and documentation centers of autonomous regions (CADIME (Centro Andaluz de Documentación e Información de Medicamentos = Andalusian Centre for Documentation and Information on Medicinal Products), CEVIME (Centro vasco de información de medicamentos = Basque Medicines Information Centre), CANM, etc.)
The Medicines Information and Documentation Centers of the Autonomous Communities publish reports on the evaluation of medicines, classify them according to the degree of therapeutic innovation and make recommendations on use, which are of great value due to their quality and independence from the promotional environment. In recent years, coordination programs have been set up among the different centers, developing common methodology and criteria for the evaluation of new medicines. The growing involvement between primary and specialized care, together with the role of the hospital in integrated health areas, opens up the expectation of collaboration. The GENESIS group plans to collaborate with these centers to develop methodology and models for the coordinated evaluation of new medicines, as well as to provide specific criteria and knowledge from the hospital's perspective.
Health Technology Evaluation Agencies
These agency reports based on applying EBM are good models in terms of documentation systems and methodology for technology evaluation. Their reports are preferably geared towards extracting and summarizing evidence from technologies for which there is extensive expertise and literature. Although their contribution to new medicines is smaller, collaboration with them has produced quality reports, and their experience can be of great use to us, so that lines of collaboration may be considered in the pursuit of the GENESIS group's objectives.
Specific groups
There are different groups of hospital pharmacists working in specific areas within the SEFH (e.g., Pediatric Pharmacy Group, HIV Group) or independently (e.g., GEDEFO, the Spanish Oncology Pharmacy Development Group). The members of these groups, as experts in defined therapeutic areas, can contribute their experience and criteria to the evaluation process. GENESIS will contact these groups to collaborate and share work in this field.