Currently, medication errors remain a leading cause of preventable harm in healthcare systems around the world,1 even though the last 2 decades have seen considerable progress in knowledge about and implementation of strategies and safety practices to prevent them.2 According to a recent report,3 within member countries of the Organization for Economic Cooperation and Development (OECD), as many as 1 in 10 hospital admissions is caused by an adverse event related to medications, and as many as 1 in 5 patients suffer harm associated with medications during their hospital stay, globally all at a cost of 54 billion dollars in OECD countries.

Improving medication safety in hospitals requires the implementation of multiple safety practices in each and every stage of the medication use system, given their extraordinary amplitude and complexity. The approach must be multidisciplinary and must include all healthcare professionals involved in medication use. In order to achieve improvements, numerous organizations have recommended that a multidisciplinary team at each hospital periodically use a proactive self-assessment tool to evaluate safety in the medication use system and identify risks and opportunities for improvement, with such information being applied toward prioritizing and planning safety practices to be implemented.4–6

To this end, in 2007, the Ministry of Health published the “Medication Use-System Safety Self-Assessment for Hospitals”,7 which is an adaptation to Spanish healthcare practice of the Medication Safety Self-Assessment for Hospitals, originally developed by the Institute for Safe Medication Practices (ISMP). Using this questionnaire, the Ministry of Health and ISMP-Spain, with collaboration from the autonomous regions in Spain and the Spanish Society of Hospital Pharmacy (SEFH), carried out 2 national studies, one in 2007 and another in 2011,8,9 that provided information about the implementation of medication safety practices in Spanish hospitals, information that was used to prioritize practices to be included in patient safety strategies at various levels.

In 2018, the Spanish survey was updated10 to reflect new best practices from updates made earlier in the United States, Australia, and Canada.11–13 Taking advantage of its availability, the SEFH Working Group of Clinical Safety decided to conduct a new study, which was supported by the Ministry of Health. The main objective of this study was to provide updated information on the implementation of safe medication practices in Spanish hospitals. An additional objective was to encourage proactive and comprehensive assessments of the medication use systems in Spanish hospitals performed by multidisciplinary teams at each institution.

Descriptive multicenter study of the degree of implementation of the safety practices included in the “Medication Use-System Safety Self-Assessment for Hospitals. Version. II”.10 Participants in the study were Spanish hospitals that completed the questionnaire between October, 2021 and September, 2022. The survey was disseminated by the SEFH using its mailing list for members and by the Ministry of Health contacting those responsible for quality assurance in the autonomous regions. Questionnaire responses were recorded using a web-based program found on the ISMP-Spain website that guarantees confidentiality.

There were 131 hospitals from 15 autonomous regions that participated in the study, of which 112 were public and 19 private, and whose characteristics can be found in Table 1. Of these, 36.6% were hospitals with <200 beds, 35.1% with 200–499 beds, and 28.2% with ≥500 beds. With respect to type of hospital, 108 were general hospitals and 23 monographic hospitals.

Table 2 shows the overall results obtained for the questionnaire in the 131 hospitals and in the different groups established according to functional dependency, size, and type of hospital. The mean score for the complete questionnaire in all of the hospitals was 898.2 which is 57.4% of the total maximum score (1566). There was a broad range in the results obtained among the sample hospitals, ranging from 511.5 to 1409. There were no significant statistical differences among the percentages on the maximum possible scores obtained among the different groups of hospitals.

Table 3 shows the mean scores obtained for the 10 key elements in the totality of the hospitals and in the groups considered according to dependency, size, and type of hospital. It also shows the results expressed as a percentage on the maximum possible score for the key elements, which allows for making comparisons and determining those areas where there are more opportunities for improvement. No statistically significant differences were found between the results obtained in the different categories of hospitals. The lowest values were found for key elements VIII, I, and VI, on competence and training of healthcare professionals in safety practices (45.1%), availability and accessibility of essential information on patients (48%), and acquisition and use of devices for administering drugs (52.3%). Four other elements showed percentages between 50% and 60%: element V (54.9%) on drug standardization, storage, and distribution; II (57.3%) on availability of information about medications; X (57.6%) on quality and risk management programs; and IX (58%) on patient education.

Fig. 1 is a graphic representation of the results found for the key elements and for the complete questionnaire in the current study and in the study carried out in 2011, which used Version I and included 165 hospitals. A statistically significant increase of 7.7% was observed in the percentages for the complete questionnaire in 2022 as opposed to 2011, as well as differences in all of the key elements. Although the current Version II uses a tougher scoring for some items and also incorporates several new items, the scores observed for 8 key elements in 2022 were higher than those in 2011, which, indeed, reflects greater implementation of safety practices, especially in key element III (+18.9%) on communication about prescriptions and other types of medication information, for element VIII (+15.3%) on healthcare professionals’ competence and training in safety practices, and for element IV (+12.6%) on drug labeling, packaging, and naming. However, lower scores were observed for key elements VII (−3.3%) and V (−3.2%), on environmental factors and human resources, and on drug standardization, storing, and distribution, respectively, since Version II includes some new items which earned low scores. These refer to the centralized preparation of intravenous mixtures in the pharmacy service and the control of automated dispensing systems, as well as the provision of trained personnel for handling and maintaining new technologies, and of pharmacists for specialized areas of work.

Fig. 1.

Results obtained for the 10 key elements and for the complete questionnaire expressed as percentages on the maximum possible scores in this study (n = 131 hospitals) and in the previous 2011 national study using Version I of the questionnaire (n = 165 hospitals).

Abbreviated description of the key elements: I. Availability and accessibility of patient information. II. Availability and accessibility of information about medications. III. Communication of drug orders and other types of medication information. IV. Drug labeling, packaging, and naming. V. Drug standardization, storage, and distribution. VI. Acquisition, use, and monitoring of devices for administering medications. VII. Environmental factors and human resources. VIII. Competence and training of healthcare workers in medications and safety practices. IX. Patient and family education. X. Quality programs and risk management.

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It is not possible to include the results obtained for each and every evaluation item in this article. Table 4 serves to illustrate the scores obtained for several items related to the safe use of high-risk medications and to medication reconciliation, which are considered priority areas in the third challenge of the World Health Organization (WHO), as well as for the incorporation of clinical pharmacists in healthcare teams and for technologies that impact safety, as recommended by expert organizations because of their proven efficacy in reducing medication errors. With respect to high-risk medications, low implementation percentages for the majority of items were observed, especially for item 120 (23.3%) which refers to removing vials or ampoules of concentrated potassium and electrolytes from patient care units, item 98 (32.4%) on centralized preparation in the pharmacy service of standardized intravenous solutions of high-risk medications, and item 205 (26.7%) on providing information about these medications to patients at the time of discharge. As far as establishing medication reconciliation practices, the mean percentages showed a broad range of improvement, both for reconciliation at the time of hospital admission (58.5%), when transferring patients to a different unit (60.3%), at discharge (52.7%) and in ambulatory care units (47.7%).

It was also possible to observe a low degree of incorporation of clinical pharmacists in hospitals units (39.2%) and in ambulatory care units (35.8%), which corresponds to the fact that the number of specialist pharmacists working in clinical units was considered insufficient by the participants (54.2%). Finally, with respect to the implementation of new technologies, higher scores were reported for electronic prescription with clinical decision-support systems (66%) and for electronic medication administration record (81.9%), and a low degree of implementation of barcode reader use in dispensing (28.7%) and when administering medications (21%).

This study provides detailed, up-to-date information regarding the implementation of safe practices in the medication use systems in Spanish hospitals, and will be of great usefulness at a critical moment when the WHO and other organizations are stressing the need to promote actions that will improve medication use safety, cognizant of the fact that preventable harm caused by medications constitutes an important concern for healthcare systems all over the world and that the problem has only been made exacerbated by the COVID-19 pandemic.1,3,14,15

The results obtained show that appreciable advances have been made in the degree of implementation of some safety practices, yet there remains a broad margin for improvement if we are to truly reduce the risks associated with medication use in our hospitals. Moreover, the results reveal that the degree of implementation of safety practices is not the same across all hospitals. All of this reflects the great complexity and difficulties that we face when incorporating safe practices into the reality of hospital care.

It should be pointed out that multiple practices designed to improve the safety of high-risk medications and the continuity of medication during transitions of care continue to be poorly implemented, despite their being included in the National Strategy for Patient Safety16 and among the priority lines of the WHO.14 With respect to high-risk medications, the practice most widely implemented is having available at the hospital a list of high-risk medications, though this measure is of little value in itself if not accompanied by other more effective general or specific strategies, such as the inclusion of alerts within computer systems, standardization of concentrations of solutions for infusion and their preparation in the pharmacy service, restriction of potassium concentrates and neuromuscular blockers in the care units, etc.17,18 On the other hand, although the importance of implementing medication reconciliation procedures has been stressed,19,20 their incorporation into healthcare practice is still limited because they require infrastructures, human resources, and technologies that may not be available.

Scores were also low for those elements related to healthcare professionals’ competence and training with regard to error reduction practices and to educating patients and caregivers about medications, aspects that, according to the third challenge of the WHO, are fundamental pillars for improving safety,14 but ones that have not been integrated in organization and treatment procedures in our hospitals.

The study once again reveals that the incorporation of clinical pharmacists into our healthcare teams is sparse as is the provision of technologies that allow full traceability throughout the medication use system, such as barcode readers for use in dispensing and administration. This information coincides with data provided by The White Book SEFH-2019.21 Certainly, implementation of these practices has been for years and continues to be advocated by hospital pharmacists,22,23 since these practices have been shown to be among the most effective for reducing medication errors,24–27 but their implementation in our country is still lower than in others.28,29 One possible strategy for achieving a higher degree of implementation of safe practices as well as greater consistency among our hospitals would be to establish a certification system that would set minimum compulsory standards and, also, provide the resources necessary to guarantee those standards.

Finally, it should be pointed out that we believe this study has encouraged hospitals to use the self-assessment questionnaire and, in doing so, has also promoted analyses and reviews of all the processes in the medication use system and has identified areas of greatest risk, something that will incentivize healthcare professionals to seek measures for making improvements.

This study has numerous limitations stemming from the methodology used. First of all, there are the limitations associated with the inaccuracy of the self-assessment questionnaire, since it is really conceived as a tool for continuous quality improvement. Thus, interpretation of the different items on the questionnaire by the teams at each hospital may vary and affect results. In addition, although the instructions emphasize the importance of having a multidisciplinary group who are familiar with the reality at the hospital responding to the items with rigor and frankness, no control was carried out to verify compliance with these instructions, nor the veracity of the data recorded. Finally, we should point out that participation in the different autonomous regions was uneven and the hospitals were not randomly selected. Moreover, the hospitals that voluntarily decided to participate could be more sensitive and might put more effort into medication error prevention, which could have introduced bias into the results.

In conclusion, this study shows that appreciable advances have been achieved in the degree of implementation of some safe medication error prevention practices in Spanish hospitals, but numerous practices of proven efficacy recommended by the World Health Organization and by safety organizations are still only poorly implemented. The information we obtained from this study should prove useful for prioritizing the practices to be addressed and, also, as a new baseline for monitoring progress.

The results of this study provide detailed, up-to-date information about safety in the medication use system in Spanish hospitals and should prove quite useful for prioritizing the practices to be addressed in efforts to make improvements.

The study clearly shows that appreciable advances have been made in the degree of implementation of some safety practices, though there is still ample room for improvement in order to achieve further reduction in the risks associated with medication use in hospitals.

The article being submitted does not contain any identifiable patient data.

This study was carried out with the support of the Spanish Society of Hospital Pharmacy (SEFH).

This study was coordinated by MJO and JMC. All of the authors participated in disseminating the study and gathering information. The preliminary analysis and interpretation of the data was performed by MJO and MPE, and were later reviewed by the rest of the authors. All of the authors reviewed and contributed to writing the manuscript and approved the final version offered for publication.