Safety in the use of medicines has become a priority of health systems worldwide. Medication errors (MEs) result in the occurrence of adverse events in patients, have a psychological impact on the healthcare professionals involved, and may ultimately cause a loss of trust in institutions. According to the World Health Organization (WHO), MEs cause at least one death every day and injure approximately 1.3 million people annually in the United States.1 Specifically, high-alert medications (HAMs) have become a priority issue for international, national and regional health authorities.

HAMs are medications with a higher potential for causing severe or life-threatening harm when administered improperly. Healthcare authorities and scientific societies have given priority to HAM safety best practices to prevent medication errors and minimize potential damage to patients. The concept of ‘high-alert medications’ emerged from the need for defining target medicines on which efforts should be focused. The identification of priority medicines facilitates the development of interventions for improving patient safety, in view of the high complexity of medication use processes and the large number of medications available.2

The third WHO global patient safety challenge “Medication Without Harm” urged its members to focus their patient safety efforts on three priority areas, including high-risk situations, which involve HAMs.3

The Spanish Ministry of Health, in collaboration with the autonomous communities, promoted the implementation of safety practices for HAMs through the Patient Safety Strategy of the National Health System (2015–2020 period). This Strategy is aimed at fostering the implementation of HAM-related safety practices and includes recommendations to establish specific interventions to prevent the most frequent errors in the use of these medications.4

Given the relevance of HAMs for patient safety, a multidisciplinary Program was designed to pursue a comprehensive approach to the use of HAMs in adult patients hospitalized in a class-5 hospital.5 This Program was developed within the framework of a local patient safety Program coordinated by the hospital pharmacists, where physicians and the nursing staff of different specialties and areas were actively involved.

The purpose of this publication is to share our experience in the implementation of safety practices for the use of HAMs in the hospital setting.

The objectives of our project included (i) adapting widely accepted national and international standards and best practices for the safe use of HAMs; (ii) developing a protocol that establishes the duties and responsibilities of the professionals involved; (iii) promoting the engagement of all the stakeholders involved in the safe use of medicines; and (iv) selecting a set of assessment items to identify areas for improvement.

The project was divided into three phases. In the first phase, an analysis of baseline HAM-related safety practices was performed. Secondly, a local safety protocol was designed for these medications. Finally, a plan of action was developed for the dissemination and monitoring of the protocol.

The scores obtained by our hospital in the self-assessment questionnaire for HAM-related items are shown in Table 1.

The main bibliographic databases were searched for relevant papers on safety medication practices. Based on the results of the review, a local protocol was designed entitled Using high-alert medications safely.

A review of the following recommendations from relevant authorities was performed to identify best practices:

WHO: Medication safety in high-risk situations.3

Ministry of Health: Practices to improve HAM safety.7

ISMP: Medication Safety Self Assessment for Hospitals (version 2).6

ISMP: List of HAMs.8

Recommendations for the safe use of automated medication dispensing systems, prepared by the ISMP in collaboration with the TECNO task group of the Spanish Society of Hospital Pharmacy.9

The Protocol included seven general safety measures related to the use of HAMs:

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  Establish a list of the HAMs available at the hospital (see Annex).

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  Provide training and education to the healthcare professionals involved in the HAM administration process.

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  Provide access to this Protocol and the HAM list on the hospital Intranet to all local professionals.

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  Promote the reporting of detected errors to the Integrated Safety and Emergency Center (CISEM).

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  Change the name of “look alike/sound alike” high-alert medications using highlighted Tall Man lettering10 on unit-dose packages, electronic prescriptions, automated dispensing cabinets (ADCs) and other automated systems for the administration of AHMs.

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  Foster communication between the Hospital Pharmacy and other local clinical units by disseminating alerts and relevant drug-related information among supervisors via email; disseminate this information to all the professionals involved in the administration of these medications.

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  Monitor the level of implementation of specific detailed measures in the protocol based on the use of indicators.

The Protocol includes 30 specific measures to be implemented at all stages of the medication use process (Table 2).

Five items were established to assess the level of compliance with some of the measures. Items were selected by consensus considering their suitability for automated computation. Table 2 shows the specific measure that is evaluated with each item. The indicators selected included:

• 1.

  Availability of an updated protocol (maximum validity of 2 years) for a safe use of HAMs including a list of ingredients (Yes/No).

• 2.

  Number of HAMs stored in high- or maximum-security locations/total number of HAMs in the ADC, except for thermolabile medications (>70%).

• 3.

  Number of medications labeled as HAMs in the computerized order entry system and the ADC/number of true HAMs (>90%).

• 4.

  Number of pharmaceutically validated HAMs/number of HAMs prescribed via the electronic prescribing system (>70%).

• 5.

  Number of pharmacy interventions in relation to the HAMs prescribed/Number of HAM prescribed (without a reference value).

It was agreed to update the Protocol biannually and perform item monitoring annually.

The milestones achieved by the Medication Safety Task Group throughout 2023 included:

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  Identification of HAMs in electronic prescriptions with the standard symbol established by the Spanish Ministry of Health and the ISMP.

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  Modification of the name of “look alike/sound alike” HAMs by adopting Tall Man lettering in unit-dose packages, electronic prescriptions, ADCs and other automated systems related to medication use.

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  Inclusion of an alert in ADCs on the need for an independent double check every time a HAM is administered to a patient.

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  Integration of maximum dose alerts for HAMs in electronic prescriptions. A total of 5361 alerts were included for 213 active ingredients. Alerts reported the maximum daily dose per administration and weight, for the different age ranges (newborns, infants, preschoolers, schoolchildren, adolescents, adults and older adults).

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  Calculation of the items suggested, with 71.51% of HAMs stored in high-security AD compartments; 100% of HAMs identified as such in electronic prescriptions; 71.36% of HAMs validated within the first 24 h following prescription; and 4366 pharmacy interventions related to HAMs (with 72.3% having been accepted).

A comprehensive HAM use Program was developed in a class-5 hospital. The Protocol was developed taking into account the items for improvement identified through the ISMP self-assessment questionnaire. The areas for improvement identified included: design and dissemination of a HAM list; availability of protocols, guidelines, dosing scales or checklists; and restricted access to neuromuscular blockers and potassium chloride concentrate vials. To address these areas, the Protocol included labeling HAMs as high-alert medications in information systems, using Tall Man lettering, and storing HAMs in high-security ADC compartments.

One of our main achievements was the adaptation of the safety practices recommended by agencies such as the WHO to the characteristics of our hospital. Later, after our Program was implemented, in 2023, the Ministry of Health published its Safety HAM Practices which included most of the measures adopted in our hospital.17 In 2023, a survey was conducted to assess the level of implementation of the Ministry's Safety HAM Practices. As compared to other participating hospitals, our hospital had a lower score in some items (such as HAMs list dissemination or restriction of potassium chloride concentrate ampoule/vial stock), which indicates that some measures need to be adopted or intensified to prioritize these items.18

Collaboration between the Pharmacy Department, information systems and technology equipment made it possible to include alerts in computerized order entry systems and ADCs, thereby facilitating HAM traceability and ultimately minimizing errors. The participation of multidisciplinary teams, added to institutional support, was key to the success of the Program, which promoted a safety culture.

One of the strengths of this project lies on the design and use of items that enable the continuous evaluation of the Program. These items will help identify areas for improvement as the hospital environment changes and new technologies become available.

One of the limitations of this project is that protocols and operating procedures need to be periodically updated and reviewed. This is necessary to guarantee their validity and ensure compliance with the standards or recommendations of patient safety agencies. Another limitation was that removal of concentrated potassium chloride vials from wards was not included in the first phase. The reason was that adopting this measure would have delayed the implementation of the other measures. A variety of strategies are currently under consideration, such as the standardization of fluid replacement therapy to facilitate the integration of this measure in a near future.

This unprecedented experience in the implementation of safety practices throughout the whole HAM administration process in the hospital setting is applicable to other centers. The strategic development of a national standardized dashboard would ensure the homogeneity and comparability of data across centers. Additionally, this tool would help identify best practices and areas for improvement.

In conclusion, the Program demonstrated to be an effective, applicable tool for ensuring patient safety in relation to the use of HAMs in a complex hospital setting. The implementation of this comprehensive, multidisciplinary approach represents a significant step forward in reducing high-alert medication errors in the hospital setting.

Canales-Siguero Maria Dolores: Writing – original draft, Methodology, Conceptualization. Caro Teller Jose Manuel: Supervision, Project administration, Methodology, Data curation, Conceptualization. Pablos Bravo Siria: Validation, Supervision, Project administration, Methodology, Conceptualization. Quintana Estelles Delicias: Visualization, Project administration, Methodology, Conceptualization. Gomis Muñoz Pilar: Supervision, Resources, Project administration, Conceptualization. Tejido Sanchéz Angel: Visualization, Project administration, Methodology, Conceptualization. Ferrari Piquero Jose Miguel: Visualization, Validation, Supervision, Resources, Project administration, Methodology, Conceptualization.

The authors did not receive any funding for the preparation of this manuscript.