RELEVANT MILESTONES FOR THE GENESIS WORKGROUP
9 November 2017
SEFH’s Position Paper on biosimilar medicines. 17 October 2017.
Access the document. Key points
19 January 2017
Conference on the economic evaluation of drug selection. Genesis SEFH.
26 July 2016
SHARED STANDARDIZED WORK PROCEDURES, VERSION 2.0, June 2016.
Standardized work protocol for preparing collaborative reports by SEFH’s GENESIS workgroup. June 2016. Click here
26 July 2016
Code of Ethics of the GENESIS-SEFH workgroup. June 2015. Click here
21 November 2015
Presentation of the Joaquin Bonal medal to Francesc Puigventos Latorre at the 60th SEFH Congress.
27 October 2015
STEERING GROUP 2015
Coordinator: Maria Dolores Fraga Fuentes. This email address is being protected from spambots. You need JavaScript enabled to view it.;This email address is being protected from spambots. You need JavaScript enabled to view it.
Deputy coordinator: Eduardo Lopez Briz. This email address is being protected from spambots. You need JavaScript enabled to view it.
Other members of the steering committee: Emilio Jesus Alegre del Rey; Rocio Asensi Diez; Vicente Arocas Casañ; Ana Clopes Estela; Sandra Flores Moreno; Ana Lozano Blazquez; Roberto Marin Gil; Noemi Martinez Lopez de Castro; Iciar Martinez Lopez; Ana Ortega Eslava; Francesc Puigventos Latorre; Jesus Francisco Sierra.
18 September 2014
Instructions and allegations model for shared GENESIS-SEFH reports: Click here
30 June 2014
STEERING COMMITTEE 2014
New steering committee members in 2014: Ana Lozano.
Coordinator: Roberto Marin Gil. This email address is being protected from spambots. You need JavaScript enabled to view it.
Deputy coordinator: Maria Dolores Fraga Fuentes. This email address is being protected from spambots. You need JavaScript enabled to view it.;This email address is being protected from spambots. You need JavaScript enabled to view it.
Other members of the steering committee: Emilio Jesus Alegre del Rey; Rocio Asensi Diez; Vicente Arocas Casañ; Javier Bautista Paloma; Ana Clopes Estela; Sandra Flores Moreno; Eduardo Lopez Briz; Ana Lozano Blazquez; Noemi Martinez Lopez de Castro; Iciar Martinez Lopez; Ana Ortega Eslava; Francesc Puigventos Latorre; Jesus Francisco Sierra.
22 January 2014
MEDICINES EVALUATION CONFERENCE
Presentation of the MADRE version 4.0 methodology. Madrid 14 January 2014. Ministry of Health Auditorium: Click here
20 December 2013
CONFERENCE ON DRUG EVALUATION. 14 June 2014: PRESENTATION OF THE MADRE VERSION 4.0 METHODOLOGY.
Access the Conference agenda: here
Access the Conference presentations: here
11 October 2013
RULES FOR SUBMITTING REPORTS TO THE GENESIS WEBSITE
The number of reports on the GENESIS website has grown significantly in the last few months. On many occasions, the reports are prepared by a team of GENESIS members and on others they have been drafted by hospital personnel or by groups or committees dedicated to drug evaluation in different autonomous regions (Pharmacotherapeutic guidelines of Andalusia, Catalonia, etc.). For that reason, a decision was made to classify the reports posted in the GENESIS website into the following categories:
Reports prepared by hospital personnel:
O: ORIGINAL REPORT: Prepared without using the reports published on the GENESIS website as a model.
A: UPDATED REPORT: They are updates of an old report published on the GENESIS website that include relevant new information.
P: ADAPTED REPORT: Prepared on the basis of some other report published on the GENESIS website introducing small modifications but without adding any new information.
Types of reports prepared collaboratively within the GENESIS workgroup:
B: BASIC: These are documents containing “basic information” about a drug. They are evaluation reports prepared following the MADRE methodology, with several sections of the document being pre-filled. These documents are drafted by the workgroup members themselves, without links to any hospital.
PUBLIC DRAFT REPORT: These are preliminary public reports prepared at the proposal of the GENESIS workgroup and drafted following the shared procedure. They are available to the public, who are entitled to file allegations. The document will be considered a public draft until all allegations have been analyzed.
FINAL VERSION: These reports are prepared at the proposal of the GENESIS workgroup. They are drafted following the shared procedure and are required to undergo a public display procedure. This is basically the public draft report, once any allegations have been analyzed.
When submitting a report to be uploaded to the GENESIS website, authors must state the type of report they are submitting, with the corresponding acronym appearing next to the medication/indication in question on the GENESIS website. It would be advisable for this classification to be also included in the DRUG IDENTIFICATION AND AUTHORS OF THE REPORT section in the first part of the report. The reference number of the report and information on whether it has been updated or adapted should also be included. For confidentiality reasons, the name of the department and of the applicant should be kept out of the report and replaced by XXX.
Reports uploaded to the GENESIS website should be prepared following the MADRE methodology; they should also be up to date. If a submitted report does not refer to a drug already covered by other reports on the GENESIS website, the time elapsed between their date of completion and their date of submission should not exceed one year. If other reports on the drug exist on the website, this period should not be longer than 6 months.
The email attaching the report to be uploaded to the GENESIS website should contain the following data:
ACTIVE INGREDIENT:
INDICATION:
TYPE OF REPORT:
Original/Adapted/Updated
HOSPITAL NAME:
DATE OF COMPLETION OF THE REPORT (MONTH-YEAR):
FORMAT (WORD/PDF):
TO BE PUBLISHED IN THE BLUE/RED AREA:
To publish a drug evaluation report, please submit it to Maria Dolores Fraga Fuentes.This email address is being protected from spambots. You need JavaScript enabled to view it.;This email address is being protected from spambots. You need JavaScript enabled to view it.
View detailed instructions: here
31 May 2013
STEERING COMMITTEE 2013
New steering committee members 2013: Emilio Alegre, Javier Bautista.
Coordinator: Ana Clopes Estela. This email address is being protected from spambots. You need JavaScript enabled to view it.
Deputy coordinator: Francesc Puigventos Latorre. This email address is being protected from spambots. You need JavaScript enabled to view it.
Other members of the steering committee: Emilio Jesus Alegre del Rey; Rocio Asensi Diez; Vicente Arocas Casañ; Javier Bautista Paloma; Sandra Flores Moreno; Maria Dolores Fraga Fuentes; Eduardo Lopez Briz; Roberto Marin Gil; Noemi Martinez Lopez de Castro; Iciar Martinez Lopez; Ana Ortega Eslava; Jesus Francisco Sierra.
29 May 2013
MADRE-METHODOLOGY VERSION 4.0
Publication of version 4.0 of the MADRE (Método de Ayuda para la toma de Decisiones y la Realización de Evaluación de medicamentos) methodology Click here
SHARED STANDARDIZED WORK PROCEDURES, VERSION 1.0, March 2013
Publication of the Standardized Work Protocol for the preparation of collaborative reports by the GENESIS workgroup. March 2013. Click here
27 July 2012
STEERING COMMITTEE 2012
New members in 2012: Vicente Arocas, Sandra Flores, Iciar Martinez and Jesus Francisco Sierra.
Coordinator: Ana Clopes Estela. This email address is being protected from spambots. You need JavaScript enabled to view it.
Deputy coordinator: Francesc Puigventos Latorre. This email address is being protected from spambots. You need JavaScript enabled to view it.
Other members of the steering committee: Rocio Asensi Diez; Vicente Arocas Casañ; Sandra Flores Moreno; Maria Dolores Fraga Fuentes; Eduardo Lopez Briz; Roberto Marin Gil; Iciar Martinez Lopez; Noemi Martinez Lopez de Castro; Ana Ortega Eslava; Francisco Sierra Garcia; Jesus Francisco Sierra Sanchez.
19 May 2012
GENESIS-SEFH DOCUMENTS
Hospital pharmacy and the new challenges inherent in drug selection in Spain: The experience gained from serving the community. May 2012. For more information. {modal url=genesis/Enlaces/DOCUMENTO_MINISTERIO_21_05_2012.pdf}Enlace{/modal}
3 September 2011:
STEERING COMMITTEE 2011
New members in 2011: Roberto Marin and Francisco Sierra.
Coordinator: Ana Clopes Estela. This email address is being protected from spambots. You need JavaScript enabled to view it.
Deputy coordinator: Francesc Puigventos Latorre. This email address is being protected from spambots. You need JavaScript enabled to view it.
Other members of the steering committee: Rocio Asensi Diez; Maria Dolores Fraga Fuentes; Eduardo Lopez Briz; Roberto Marin Gil; Noemi Martinez Lopez de Castro; Ana Ortega Eslava; Maria Teresa Pozas del Rio; Francisco Sierra Garcia; Pere Ventayol Bosch.
23 May 2011:
RESEARCH:
Study on the “Current situation of the structure and results of the drug selection procedure followed by Spanish hospitals” (FIS project). Presentation of results. For more information, {modal url=genesis/investigacion/proyectos/fis-2011/FIS2.htm}Enlace{/modal}
26 March 2010:
GENESIS WEBSITE TRAFFIC REPORTS
Since June 2009, the GENESIS workgroup has been monitoring access to its website using the GOOGLE ANALYTICS tool. Half-yearly reports shall be prepared with the information provided by this tool on traffic parameters, visitors’ location, most frequently browsed sections, etc. The data shall be made available to all workgroup members in the links of interest section. A password will be necessary to access the information.. Click here. . Access the latest report.
7 November 2009:
STANDARDIZED WORK PROCEDURE
"Off-label use of medicines”
Proposal by the GENESIS workgroup of a standardized work procedure for the in-hospital use of off-label drugs. Draft 7 Nov 2009: Click here
24 September 2009:
RULES TO BE FOLLOWED TO SUBMIT REPORTS TO THE GENESIS WEBSITE
Given the increase in the number of reports hosted in the GENESIS website, many of them updates of existing reports, basic reports prepared by the GENESIS workgroup and public drafts put together for the Pharmacotherapeutic Guidelines of Andalusia, a decision was made to classify reports into the following types:
B: BASE: These are documents containing “basic information” about a drug. They are evaluation reports prepared following the MADRE methodology, with several sections of the document being pre-filled. These documents are drafted by the workgroup members themselves, without links to any hospital.
O: ORIGINAL REPORT: Prepared without using the reports published on the GENESIS website as a model.
A: UPDATED REPORT: They are updates of an old report published on the GENESIS website that include relevant new information.
P:
ADAPTED REPORT: Prepared on the basis of some other report published on the GENESIS website introducing small modifications but without adding any new information.
PUBLIC DRAFT REPORT: These are public preliminary reports prepared at the proposal of the GENESIS workgroup. A period is allowed for making allegations.
FINAL REPORT: These are reports validated following an analysis of the allegations submitted.
When submitting a report to be uploaded to the GENESIS website, authors must state the type of report they are submitting, with the corresponding acronym appearing next to the medication/indication in question on the GENESIS website. It would be advisable for this classification to be also included in the DRUG IDENTIFICATION AND AUTHORS OF THE REPORT section in the first part of the report. The reference number of the report and information on whether it has been updated or adapted should also be included.
ACTIVE INGREDIENT:
INDICATION:
REPORT TYPE: B, O, A, P,
Draft, Final version
NAME OF HOSPITAL:
DATE OF COMPLETION OF THE REPORT (MONTH-YEAR):
FORMAT (WORD/PDF):
TO BE PUBLISHED IN THE BLUE/RED AREA:
To publish a drug evaluation report, please submit it to Maria Dolores Fraga Fuentes.This email address is being protected from spambots. You need JavaScript enabled to view it. ; This email address is being protected from spambots. You need JavaScript enabled to view it.
Detailed instructions are available: here
New steering committee members in 2010: Rocio Asensi, Eduardo Lopez, Noemi Martinez and Maria Teresa Pozas
Coordinator: Bernardo Santos Ramos.This email address is being protected from spambots. You need JavaScript enabled to view it.
Deputy coordinator: Ana Clopes Estela.This email address is being protected from spambots. You need JavaScript enabled to view it.
Members in charge of reports: Emilio Alegre, Montse Vilanova, Rocio Asensi, Noemi Martinez and Maria Teresa Pozas
Members in charge of research and training: Francesc Puigventos, Ana Ortega, Pere Ventayol, Eduardo Lopez and Maria Dolores Fraga
Members in charge of the website: Maria Dolores Fraga and Montse Vilanova
SEFH liaison officer: Bernardo Santos
Previous coordinators:
Ana Ortega Eslava. 2009-2010. This email address is being protected from spambots. You need JavaScript enabled to view it.
Teresa Requena Caturla. 2007-2008. This email address is being protected from spambots. You need JavaScript enabled to view it.
Francesc Puigventos Latorre.2005-2006. This email address is being protected from spambots. You need JavaScript enabled to view it.
Genesis steering committee 2009:
GENESIS workgroup steering committee 27 February 2009
New steering group members in 2010:
Maria Reyes Abad Sazatornil. Miguel Servet University Hospital. Zaragoza
Rocio Asensi Diez. Carlos Haya Regional University Hospital. Malaga
Eduardo Lopez Briz. La Fe University Hospital. Valencia
Maria Teresa Pozas del Rio. Niño Jesus University Children’s Hospital. Madrid
Maria del Pilar Prats Olivan. Gomez Ulla Military Hospital, Madrid.
Piedad Toro Chico. Alcorcon Foundation University Hospital. Madrid
Educational activities:
- Conference on indirect comparisons and their application to drug evaluation. 18 November 2010. Coordinators: Anna Clopes and Pere Ventayol. View brochure.
- New courses for members of hospitals’ pharmacy and therapeutics committees, in collaboration with the Andalusian Public Health School. Coordinators: Anna Clopes and Pere Ventayol.
- 2nd pre-congress course on “Medicines Evaluation and Selection”. 54th SEFH Congress, Zaragoza. 22 September 2009. Coordinators: Pere Ventayol and Anna Clopes.
Participation in congresses and conferences
55th SEFH Congress
Madrid 20 September 2010
GENESIS panel. Presentation of research project results
View the presentations {modal url=genesis/Enlaces/Portal_Proyecto_FIS_Avance_resultados.htm}Enlace{/modal}
54th SEFH Congress
Zaragoza 23 September 2009
GENESIS panel. Presentation of research project results
Chair: Bernardo Santos
View the presentations: {modal url=genesis/Enlaces/Portal_Proyecto_FIS_Avance_resultados.htm}Enlace{/modal}
13th SESPAS Congress
Seville 6 March 2009. SPONTANEOUS PANEL VI
Drug selection in Spanish hospitals
Chair: Ana Ortega Eslava. Coordinator of SEFH’s GENESIS workgroup
View presentations : {modal url=genesis/Enlaces/Portal_Proyecto_FIS_Avance_resultados.htm}Enlace{/modal}
Drug evaluation benchmarking conference
Barcelona 25 & 26 September 2008.
Lecture: The GENESIS project: In-hospital drug evaluation.
Review the presentation here
Courses of interest related to the evaluation and selection of medicines:
12th COURSE ON DRUG EVALUATION AND SELECTION (Palma de Mallorca, 20-23 May 2014)..
10th COURSE ON DRUG EVALUATION AND SELECTION (Palma de Mallorca, 8-11 May 2012).
8th COURSE ON DRUG EVALUATION AND SELECTION (Palma de Mallorca, 4-7 May 2010).
{modal url=genesis/CursoVII/VIICursoSevilla1.htm}7th COURSE ON DRUG EVALUATION AND SELECTION (Sevilla, 12-15 May 2009){/modal}
New evaluation reports
- Evaluation reports in the blue area of the GENESIS website. The site is updated regularly (at least once a month) to include new reports based on the MADRE methodology. Approximately 1,000 reports are currently available. View the reports
{modal url=genesis/Enlaces/InformesHosp_abc.htm}gruposdetrabajo.sefh.es/genesis/genesis/Enlaces/InformesHosp_abc.htm{/modal}. Aproximadamente 1000 informes disponibles
{modal url=genesis/Enlaces/InformesCentrosAuton.htm}gruposdetrabajo.sefh.es/genesis/genesis/Enlaces/InformesCentrosAuton.htm{/modal}. Aproximadamente 900 informes disponibles
Research:
- Study on the “Current situation of the structure and results of the drug selection procedure followed in Spanish hospitals” (FIS project). Preview the results {modal url=genesis/Enlaces/Portal_Proyecto_FIS_Avance_resultados.htm}Enlace{/modal}
- Survey for decision-makers: “Influence of economic evaluation studies on healthcare decision-making,” conducted by the HEALTH SERVICE OF THE CANARY ISLANDS and the UNIVERSITY OF CASTILE-LA MANCHA within the framework of the Quality Assurance Plan of the National Health Service. SEFH’s GENESIS workgroup made a significant contribution to the analysis. Click here
HOW TO JOIN THE GENESIS WORKGROUP
-A- Procedure to join the GENESIS workgroup
-B- CCriteria to be followed to publish hospital reports in the website’s blue area
-C- Procedure to withdraw from the GENESIS workgroup
-A- Procedure to join the GENESIS workgroup
Requirements:
- Candidates must apply for membership in writing
- Prospective members must meet a series of requirements related to their training and professional practice:
- They must be hospital pharmacists who:
- Are members of the pharmacy and therapeutics or the infection diseases committee of their hospital.
- Work at their hospital’s drug evaluation unit/medicines information center
- Prepare new drug evaluation reports for some clinical area in their hospital
- In special cases, other hospital pharmacists may be admitted (such as pharmacology experts or pharmacists with an interest in drug evaluation), who wish to evaluate new medicines following the GENESIS methodology.
- Commitment with the workgroup’s objectives:
- Commitment with the GENESIS workgroup’s objectives and participation in the workgroup’s activities
- Preparation of evaluation reports following the GENESIS methodology, which should be submitted for publication in the website’s blue area (public access area) or red area (restricted access area).
- Each member must submit at least two reports using the GENESIS methodology every year. The medicines to be evaluated will be selected by the evaluator themself. The GENESIS methodology may be reviewed in the (workgroup’s website). A (checklist) is available to determine the quality of the reports. These reports will be uploaded to the blue area or to the red area of the GENESIS website, as per the authors’ instructions.
- Participation in the methodology workgroups to be created.
- Participation in research projects
New members of the GENESIS workgroup shall:
- Have access to the red area of the GENESIS website. They will receive a password that they can use to review:
- Drafts and documents in the pipeline
- Reports from hospitals allowing members of the GENESIS workgroup restricted access to them
- List of drugs pending evaluation by different hospitals and by the workgroup
- Methodology workshop
- Research workshop
- Receive assistance for preparing reports for their hospital. They shall be free to adapt reports from other hospitals in the GENESIS network or GENESIS reference reports provided that they cite the report they have used as a model as the original source of their own.
Procedure:
Send this questionnaire requesting to become a member of GENESIS to the workgroup coordinator, Maria Dolores Fraga (This email address is being protected from spambots. You need JavaScript enabled to view it., This email address is being protected from spambots. You need JavaScript enabled to view it.)
Applications will be answered within a few days:
- After consulting with the members of the steering committee.
- After ensuring that they meet the admission criteria
- Depending on the number of applications received, admissions will be granted gradually so as to properly manage the expansion of the workgroup.
B- Criteria to be followed to publish hospital reports in the blue area of the workgroup’s website:
1-From January 2006, the following criteria have been followed for publishing re-ports in the website’s blue area::
- Hospitals with their own website containing internally prepared reports will include links to such reports if:
- They have been prepared from 2006 onwards
- At least one member of the hospital’s pharmacy department is a member of the GENESIS workgroup.
- Hospitals that do not have their own website: they can use the GENESIS website to publish their reports if:
- At least one of the report’s authors is a member of the GENESIS workgroup
- They have the authorization of the head of the hospital’s pharmacy department
- Reports must be prepared following the standard GENESIS guidelines and methodology, ensuring that the quality of the report has been tested against the GENESIS checklist.Access the checklist here
Note: An implementation/adaptation period will be established (until September 2006) during which reports will be accepted even if they do not follow the GENESIS model or if they do not check all the boxes on the GENESIS checklist, if, in the authors’ opinion, they are of sufficient quality or contain particularly relevant information.
2-Criteria to be followed in the website’s red area:
-Reports and draft reports prepared by members of the GENESIS workgroup which, in the opinion of their authors, should be subject to restricted access will be published in the red area.
-Authors should clearly specify that they wish their report to be published in the red area.
C- Procedure to withdraw from the GENESIS workgroup.
- If you wish to withdraw from the GENESIS workgroup, please fill in this form