In recent years, there has been a change in the care provided by the oncohematological pharmacists (FOH by its Spanish acronym) to cancer patients. It has evolved, from being professionals focused on preparation and dispensing of medicines, into developing a model focused on the needs of oncohematological patients (POH by its Spanish acronym). This change has been made possible by FOH's own training and educational background, which has contributed to adding value by being integrated into the interdisciplinary team taking care of these patients, participating in committees and clinical sessions, and contributing to the organization of functional units with direct information and health education to the patients1–3.

Many experiences show that FOHs who are integrated into these teams increase safety and improve health outcomes, through therapy selection and validation, interaction review, information and health education for patients and other practitioners, toxicity follow up and adherence monitoring, among other tasks4–7.

In Spain, the oncological pharmacy group (GEDEFO by its Spanish acronym) of the Spanish Society of Hospital Pharmacy (SEFH) developed a Strategic Plan of Pharmaceutical Care for the POH (GEDEFO 2020). Six strategic areas were established, where targets are identified to provide quality pharmaceutical care and thus achieve the maximum clinical benefit, helping to efficiently improve health outcomes. This plan aims to promote the incorporation of organizational, technological and process changes in order to improve its organization and quality, as well as its safety and comprehensive care in the pharmacotherapeutic process for POH8. Concurrently, the strategic map of pharmaceutical care for outpatients (MAPEX) includes actions to address their present and future needs, POH being a very large group that is treated in outpatient consultations at the pharmacy department and oncohematological (OH) Day Hospital9. GEDEFO 2020-MAPEX OH arises from the idea of marking future directions for Spanish Oncohematological Pharmacy Units (SOPU), as did previously the 2020 Strategic Plan for SEFH. For this SEFH strategic plan, indicators for every strategic line were quantified by measuring the starting point in 2010 and setting the standard to be achieved by 2020 in order to see the evolution of hospital pharmacy10.

The aim of this study was to determine the status of SOPU of Spanish hospitals in terms of organizational development, scientific evidence of clinical practice, implemented safety practices, quality pharmaceutical care, training, education, innovation and research in order to describe the current degree of implementation of the guidelines established in the plan, and consequently identify areas for improvement in the drug treatment process of the POH.

Observational study of two months in which a survey designed by the coordinators of GEDEFO 2020 in collaboration with the MAPEX OH group was developed. The survey was disseminated through SEFH and GEDEFO's electronic distribution lists, as well as through twitter going by @gedefo_sefh account. Access on SEFH's website was enabled during March and April 2017 for its completion.

The survey was divided into two parts. The first part studied profiles of participating hospitals, number of beds, annual patients under oral and parenteral antineoplastic therapy that received pharmaceutical care, antineoplastic preparations and annual mixtures and dispensations for outpatients clinic POH. Answers were based on data from 2016.

The second part closed questions were made for the survey to allow yes/no answers for each of the 42 objectives set in the 6 strategic lines of GEDEFO 20208, being divided into the following sections:

• 1.

  Organizational development: systems and implemented technology to manage the POH pharmacotherapeutic process, information systems available and degree of integration with other hospital systems, as well as support elements and systems to ensure traceability and safety.

• 2.

  Scientific evidence in clinical practice for evaluating and selecting drugs, protocolization and implemented clinical guidelines, and participation in the collection and analysis of health outcomes.

• 3.

  Implemented safety practices with actions aimed at improving the safety system when using drugs for OH.

• 4.

  POH pharmaceutical care for maximum clinical benefit, differentiating outpatients, hospitalized and treated in day hospital (DH) patients.

• 5.

  Training and teaching: FOH training and technical or nursing staff and degree of implementation of individualized professional development programs that cares for POH.

• 6.

  FOH participation in research and innovation projects.

Spanish hospitals were included, along with pharmaceutical SEFH partners that answered at least one question in the survey. As an exclusion criterion, receiving more than one survey per hospital was considered. Results were analyzed with Microsoft© Excel© 2011 program by the percentage of responses answered and the response rate for each option. Every answer was considered for the analysis of results, provided that at least one question had been answered.

A total of 95 hospitals responded to the survey, with the following geographical distribution according to GEDEFO areas: In Catalonia-Balearic Islands 22 hospitals, 19 in Andalusia and Badajoz, 18 in Central-Canarias, 16 in Levante area, 14 in the North area and 6 in the Northwest area

Hospital characteristics are shown in Table 1. Taking the central value of each interval as reference, set for number of patients seen with parenteral and oral chemotherapy in each hospital, it was estimated that the annual POH average was 1,201 ± 825 and 568 ± 450 respectively, ie 1,769 patients/year as a global average per hospital.

The results of the organizational development strategic line are shown in Table 2. Note that 76% of hospitals stated to have a management information system for the pharmacotherapeutic process that went from prescription to administration or outpatient dispensing of OH drugs. Only 3% of hospitals were performing outcome assessment through an integrated information management system of all drugs. This percentage increased to 11% if this follow up was done exclusively for high-impact treatments.

Out of the involved hospitals, 85% actively assessed processes and selected OH drugs, with a 77% collaboration with Medical Oncology and Hematology departments in the development of protocols and clinical guidelines. Out of FOH, 63% actively implemented programs aimed at patients receiving a pharmacotherapy based on evidence, and 88% of hospitals had standardized protocols, including medication support (97%), maximum dose (77 %), adverse events (20%), interactions (19%) and dose modifications according to toxicity or organ failure (35%), among others.

A total of 18% of FOH has participated in the preparation or review of OH drugs assessment reports with the Grupo de Evaluación de Novedades, Estandarización e Investigación en Selección de Medicamentos (GENESIS), 33% with their Autonomous Region and 17% with the Ministry of Health.

In addition, 51% actively participated in the systematic collection and analysis of health outcomes, and favored access to record-based tools records and/or massive collection or either data management.

As for safe practices, in 62% of hospitals, the department responsible for risk management programs applied to preventing medication errors in oncohematology was indeed the hospital pharmacy service (HPS). FOH participated in 83% of hospitals for the review of medication errors, taking measures to improve processes and/or evaluating conducted activities. 90% participated in establishing procedures for safe handling of chemotherapy, considering not only risks for the patient, but occupational risks as well. 89% of central hospitals handled antineoplastic preparation, and 67% managed other non-antineoplastic dangerous drugs. Conciliation was incorporated as another safety practice, performing at 57% of outpatients, 40% of inpatients and 29% of DH patients.

Regarding the strategic line 4 of pharmaceutical care in SOPU, the survey results are shown in Table 3. It should be emphasized that 42-67% of hospitals had a pharmacist with OH training, while in 53%, FOH was integrated into the support teams with defined responsibilities, and 92% had an OH pharmacist as reference.

The outcomes of the objectives of the strategic lines of training, teaching and research are shown in Table 4. There, it is shown that professional development programs of FOH were only implemented in 16% of centers, and 28% had developed profiles for professional training, directed at staff handling HPS antineoplastic drugs.

To our knowledge, this is the first time a survey is conducted to SOPUs in Spain aiming to see the degree of development and quality of pharmaceutical care under which patients are treated in these units.

The strong point of this study lies in the participation of Spanish hospitals that range in complexity, showing us a picture of the starting point that allows implementing actions that result in an improvement of pharmaceutical care and safety process.

A high degree of computerization of the pharmacotherapy management process was observed, but the level of integration with other hospital information systems, such as electronic medical records or HPS logistics system should be improved. Pharmaceutical validation is key to increasing patient safety11. The survey counted on 60% of respondents in a validation system with aid elements, where only 19% were integrated with the medical history. Therefore, FOH must access several different information systems for proper therapy validation –with the consequent chance of error in patient selection– which would stand out as an area for future improvement.

Effectiveness, safety and efficiency of a drug is known when used in clinical practice. The efficiency that is achieved in clinical trials is often superior to the effectiveness achieved in clinical practice12. This makes it necessary to measure health outcomes by re-evaluating the effectiveness of drugs under real conditions. Most of the hospitals surveyed did not have systems to measure results. Nevertheless, 51% admitted to participate in the collection and analysis.

In 2015, SEFH published “Report on the situation of hospital pharmacy services in Spain: infrastructure, resources and activity”, where a descriptive analysis of information systems and quality as well as safety, with which the work is done in HPS13. There, it was found that 90% of HPS has a barcode system as an applied technology aimed at dispensing and drug traceability. However, among the interviewed SOPU, there were very few hospitals using technology for traceability and safety in the preparation, administration or outpatient dispensing. For this regard, Ortiz-Marin et al.14 found that only 35.4% of hospitals in the Community of Madrid preparing intravenous chemotherapy have implemented bar code reading. These results are consistent with those obtained in this survey.

It was observed that FOH leads the application of the principles of evidence-based medicine, as well as the results obtained in routine clinical practice with the standardization of the protocols used. They also actively participate in the development of protocols and clinical guidelines based on scientific evidence, in collaboration with oncologists and hematologists.

Similarly, FOH leads safety practices implemented in hospitals, and actively participates in processes to prevent medication errors and increase safety in handling chemotherapy. The centralization of antineoplastic preparation should be increased to achieve greater safety for the handler15. It has also been identified the need to develop reconciliation programs to incorporate them into the validation procedure. POH is a complex patient in which the reconciliation process can provide the same benefits as any other chronic patient. González Carrascosa et al.16 showed that the implementation of a reconciliation program for DH POH decreased by 26% the reconciliation errors.

Recently, recommendations for safe handling of antineoplastic medication for cancer patients have been published. It consisted on a collaboration among SEFH, the Spanish Society of Medical Oncology and the Spanish Society of Oncology Nursing17. A list of safe practices were collected, with the commitment of all scientific societies to develop joint initiatives in order to increase safety in the treatment of POH.

Numerous national and international organizations suggest that pharmaceutical care for POH must be the same, regardless of the area where the patient is treated or if their medication is either oral or parenteral8,9,11,18,19. However, our results showed that there are differences if the patient is either seen in DH –patient with parenteral treatment–, is admitted or is an outpatient –patient with oral treatment or dispensing support at the HPS–. These differences appeared regarding validation before administration, continued availability of pharmaceutical care and the pharmacist's training who provides the aforementioned care. All these factors are areas of improvement. Prescription by the specialized practitioner and its subsequent validation by FOH increase safety in the patient, especially when it is done prior to its administration11. In this study, 93% of centers conducted this validation process by FOH for DH patients. However, there is a reduction of approximately 20% in hospitalized patients (74%) and outpatients (72%).

A survey conducted by Conde et al., and on behalf of the GEDEFO group on safe practices with oral chemotherapy in Spanish hospitals20, showed that only 26.8% (22/86) of pharmacists responsible for providing pharmaceutical care to patients under oral chemotherapy are FOH. Our results are better, since 42% of FOH caring for patients with oral drugs have OH training, although this percentage is less than that when patients are treated in DH (67%). This is due perhaps because this activity has been carried out in many hospitals by outpatient pharmacists, who, in addition, dispense drugs for many non-oncohematologic pathologies, and not all have OH training.

Other raised needs were to implement outcome assessment programs, to participate in continuity of care, or counting on adherence programs. These aforementioned adherence programs are being carried out only in 27% of hospitals, unlike other surveyed countries21,22, where most hospitals claim to have some method to follow up adherence.

Only 33% of respondent hospitals use prioritization mechanisms or stratification of patients who are candidates for pharmaceutical care. Patient stratification according to the needs of pharmaceutical care, will allow us to transform our health care approach, which serves a guide for each patient's individual needs23. Currently, a study is underway through MAPEX OH-GEDEFO 2020 to establish a stratification model with demographic, sociosanitary, and treatment-related variables.

Training needs for SOPU staff have been detected, as 20% of respondents received a specific training program for technical and nursing staff, and 16% for pharmacists. These results are far from the objectives set in the 2020 SEFH's10 Strategic Plan, where 95% of HPS hospitals must implement a program of individualized professional development for pharmacists, technicians and nurses.

Some scientific societies and governmental organizations recommend specific training that should have staff attending the POH17,24,25.

Professional accreditation by the Board of Pharmaceutical Specialties is considered a world-level reference. Spain has a number of accredited professionals that is far superior to other European countries26. It is noteworthy that 48% of respondents have answered that there were no pharmacists with specific vocational training on oncohematology, especially considering that Spain is the second country with accredited pharmacists as Board Certified Oncology Pharmacist, after United States27. This perhaps due to the fact that almost all of the surveyed hospitals belong the public system, where there are no specific profiles in commodity markets, hence only general merits are considered.

Finally, as for research, although more than half of the centers (53%) have FOH as principal investigator or collaborator in a research project in the past three years, only 26% of these counted on a publicly funded research project. The complexity of obtaining a publicly funded research project is high, synergies with established and emerging groups are needed to improve these values.

This study has some limitations that must be considered. Firstly, the wording of some questions has been interpreted differently by various centers. Moreover, the same study design may induce bias arising from the lack of objectivity of the answers, which does not accurately reflect reality. Moreover, although a minority, some questions have been answered by a small number of hospitals.

Despite all this, the survey represents an approximate location of the SOPU situation in Spain.

In conclusion, the findings show a high level of development in SOPU regarding the use of scientific evidence in assessment and implemented security practices, showing more variability in other strategic areas. These results set a starting point to work on those targets that are farther from recommended to provide our patients a quality pharmaceutical care standard.

For the design tool of SEFH's website, where survey data were collected, it has been sponsored by Novartis, not expecting any external financing for the analysis of results nor the publication of the manuscript.

All GEDEFO pharmacists who participated in the survey, belonging from the following hospitals: Catalan-Balearic area: Consorci Mar Parc de Salut Barcelona, Consorci Sanitari del Maresme, Hospital de la Santa Creu i Sant Pau, Hospital Clinic Barcelona, Hospital Comarcal Alt Penedés, Hospital de Figueres, Hospital de l'Esperit Sant, Hospital de Sabadell, Hospital Manacor, Hospital Municipal de Badalona, Hospital Sant Camil, Hospital Universitari de Tarragona Joan XXIII, Hospital Universitari Sagrat Cor, Hospital Vall d'Hebron, ICO-Hospital Duran i Rey, Hospital Mutua de Terrassa, Hospital Universitari Arnau de Vilanova-Lleida, Clínica Sagrada Familia, Hospital Comarcal de Blanes, Hospital Tortosa Verge de la Cinta, Hospital Son Espases, Hospital Can Misses. Levante area: Hospital General de Almansa, Hospital General de Castellón, Hospital General Universitario de Alicante, Hospital J.M. Morales Meseguer, Hospital Lluis Alcanys de Xátiva, Hospital Santa María del Rosell, Hospital Universitario de la Ribera, Hospital Universitario Dr. Peset, Hospital Universitario La Fe, Hospital Universitario San Juan de Alicante, Hospital Universitario Virgen de la Arrixaca, Hospital Vega Baja de Orihuela, Residencia la Cañada, Hospital General Universitario de Valencia, Hospital de Manises, Hospital Rafael Méndez. Central Canarias: Complejo Asistencial de Segovia, Fundación Jiménez Díaz, Hospital de Fuenlabrada, Hospital del Henares, Hospital del Sureste, Hospital General Universitario Gregorio Marañón, Hospital General Virgen de la Luz, Hospital Policlínico la Paloma, Hospital Ramón y Cajal, Hospital Universitario de Guadalajara, Hospital Universitario Puerta de Hierro, Hospital Virgen de Altagracia, Clínica Universitaria de Navarra-Madrid, Complejo Hospitalario de Toledo, Hospital General de Ciudad Real, Hospital Severo Ochoa, Hospital de la Zarzuela, Hospital Universitario Fundación Alcorcón. Occidental Andalusia-Badajoz: Área de Gestión Sanitaria Campo de Gibraltar, Clínica Sagrado Corazón, Complejo Hospitalario Don Benito-Villanueva Serena, Complejo Hospitalario Universitario de Badajoz, Complejo Hospitalario de Especialidades Juan Ramón Jiménez, Complejo Hospitalario Regional Reina Sofía, Hospital Universitario Virgen del Rocío, Hospital Universitario Virgen Macarena, Hospital Comarcal Valle de los Pedroches, Hospital Universitario de Jerez de la Frontera, Hospital Universitario de Puerto Real, Hospital Universitario Puerta del Mar, Hospital Universitario de Valme. Oriental Andalusia: Complejo Hospitalario Regional Carlos Haya, Complejo Hospitalario Regional Virgen de las Nieves, Hospital Comarcal de la Axarquía, Hospital Costa del Sol, Hospital de Poniente, Complejo Hospitalario de Especialidades Torrecárdenas. North: Clínica IMQ Zorrotzaurre, Complejo Hospitalario de Navarra, Hospital de Barbastro, Hospital Galdakao-Usansolo, Hospital Txagorritxu, Hospital Universitario Donostia, Hospital Universitario Marqués de Valdecilla, Hospital Universitario Miguel Servet, Hospital Fundación Onkologikoa, Clínica Universitaria de Navarra, Complejo Asistencial de Burgos, Complejo Asistencial de Palencia, Clínica Quirón Zaragoza, Hospital Universitario Basurto. Northwest: Complejo Asistencial de León, Complejo Hospitalario de Pontevedra, Complejo Universitario A Coruña, Hospital Clínico Universitario Lozano Blesa, Complejo Hospitalario Arquitecto Marcide-Profesor Novoa Santos, Hospital de El Bierzo.

Hospitals participating in the survey can know their results compared to other hospitals in the following link: http://formacion.sefh.es/cursos/plan_estrategico_farmacia_oncologica_2020/index

No conflict of interests.