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Farmacia Hospitalaria

versión On-line ISSN 2171-8695versión impresa ISSN 1130-6343

Farm Hosp. vol.44 no.2 Toledo mar./abr. 2020  Epub 28-Sep-2020 


Consensus to identify the dangerous drugs risks in hospital pharmacy services

María Ángeles Bernabeu-Martínez1  2  , Pedro García-Salom3  , Amparo Burgos-San José3  , Andrés Navarro-Ruiz4  , Javier Sanz-Valero1  6  , Carmina Wanden-Berghe5  6 

1Departamento de Salud Pública e Historia de la Ciencia, Universidad Miguel Hernández, Campus de Sant Joan d'Alacant, Alicante. Spain.

2Servicio de Farmacia de Área, Hospital General Universitario de Alicante, Alicante. Spain.

3Servicio de Farmacia, Hospital General Universitario de Alicante, Alicante. Spain.

4Servicio de Farmacia, Hospital General Universitario de Elche, Elche (Alicante). Spain.

5Unidad de Hospitalización a Domicilio, Hospital General Universitario de Alicante, Alicante. Spain.

6Instituto de Investigación Sanitaria y Biomédica de Alicante (ISABIAL-FISABIO), Alicante. Spain.



To identify the hazards and define the theoretical occupa tional risks arising from the process of handling hazard drugs in hospital pharmacy services on the basis of expert consensus.


An expert consensus was conducted (nominal group and documentary techniques) using a mixed method of two face-to-face rounds (meeting of participants and approval of proposals) and three masked rounds (individualized review). The analysis was applied to the field of hospital pharmacy. The stages of the process were desig ned using the standardized graphical Business Process Model and Notation.


A specific flowchart was obtained for the management and tra ceability of hazardous drugs. All general process phases were characte rized. A management chart included operations addressing the reception and storage, compounding, conservation, and dispensation of hazardous drugs in hospital pharmacy services. This chart provides a description of the chemical hazards and exposure routes.


The hazardous drug process should be integrated in a standard management system to improve the safety of patients and health care professionals. Efficiency can maximized and procedural incidents minimized, thereby ensuring the quality and the safety of hazardous drugs handling in hospital pharmacy services.

Once hazards are identified, risk assessment should be implemented using a systematic and preventative methodology to minimize the risk and seve rity of any adverse event.

KEYWORDS: Hazardous substances; Antineoplastic agents; Cytostatic agents; Occupational health; Quality control; Process assessment; Information management


The European Agency for Safety and Health at Work (EU-OSHA) has established that the handling of hazardous drugs (HD) is one of the most relevant risk factors for the health of healthcare workers1. The evidence for this is incontrovertible, in that it has been estimated that in Europe more than 12.7 million healthcare workers handle HDs. This figure implies that occu pational exposure may cause an estimated 2,220 new cases of leukaemia leading to 1,467 deaths among these workers in this continent2.

The National Institute for Occupational Safety and Health (NIOSH) de fines drugs as hazardous if, in animal or human studies, they demonstrate any of the following characteristics: carcinogenicity, teratogenicity or other developmental toxicity, genotoxicity, reproductive toxicity, organ toxicity at low doses, and drugs with a structure or toxicity profile similar to that of other hazardous drugs3.

Numerous studies have shown that HDs carry chemical risks for the workers who handle them4 5 6 7 8 9 10 11 12-13.

Thus, risk assessment is one of the key points in the HD handling and control process, given that its results support all the measures adopted to guarantee the safety of the process14. The scientific literature has descri bed several risk assessment models15. Although each one has its particular characteristics, all of them include the identification of process-associated hazards as an essential first step in their handling.

However, although risk assessment is a legal requirement in Spain16, and the need for it is recognised, there are few studies on HD risk analysis. In 2009, a French team of hospital pharmacists applied the "hazard analysis and critical control points' methodology to the preparation of anti-cancer drugs in pharmacy services17. To the best of our knowledge, the American Hazardous Drug Consensus Group is the only group that has proposed a specific methodology for HD risk analysis18.

Given the foregoing, and on the basis of expert consensus, the objective of this study was to identify the hazards and define the theoretical occupa tional risks arising from the process of handling HDs in hospital pharmacy services.



An expert consensus (nominal group and documentary techniques) was conducted using a mixed method of two face-to-face rounds (group meeting and approval of proposals) and three blinded rounds (individual review of the material). The study was conducted between November 2018 and May 2019.

Expert group

  • The following objective criteria were used to select the expert group:

  • Previous knowledge and experience: more than five years of professio nal experience in posts in which HDs are handled or risk assessment is performed.

  • Setting: primary care, hospital care, home care, or public healthcare.


Consensus was developed in seven phases:

  • Phase 1 (prior to the expert consensus): Bibliographic review of the an tecedents and protocols related to monitoring hazards (controlled fee dback), through the identification, collection, and analysis of documents related to the issue or setting under study. This review was published in 201819.

  • Phase 2 (Nov-Dec 2018): Preparation of the initial documentation and construction of the first flowchart and the HD management chart.

  • Phase 3 (masked) (Jan 2019): Review of this material and corrections.

  • Phase 4 (face-to-face) (February 2019): Sharing the contributions and document correction.

  • Phase 5 (masked) (March 2019): New document revision and new con tributions if needed.

  • Phase 6 (face-to-face) (April 2019): Acceptance of the latest revisions and production of corrected material.

  • Phase 7 (masked) (May 2019): Final unanimous approval of the mate rial: flowchart and HD management chart.

Setting of the analysis

The analysis was applied to the setting of hospital pharmacy.

Stages of the process

The Business Process Model and Notation (BPMN) was used to design the flowchart of the general scheme of the operational management of the HD logistics chain in hospital pharmacy services. Based on this flow chart, we developed total traceability management for each of the stages, created their BPMN diagrams20, and developed the corresponding HD management chart. This model was previously implemented by Bernabeu Soria et al.21. It was used to analyse and characterize each of the steps within the process, thereby facilitating the analysis of each step and the de termination of potential hazards. This technique was successfully implemen ted and verified by Cervera Peris et al.22. If needed, this technique allows processes to be easily scaled (i.e. extended), thereby maintaining efficiency and effectiveness when there is any change or new requirement. The steps to be managed were obtained from the systematic review conducted by Bernabeu et al.9: reception and bulk storage, preparation, drug storage, and dispensing.

On-site check

Based on the documents developed, we identified each of the stages, operations, and possible control points. Subsequently, we verified the co rrespondence between the documents developed (i.e. flowchart and HD management chart) and the stages comprising the HD manipulation process in the places where the operations are conducted.


The following lexicon was accepted and used in the creation of the documents:

  • Process: a set of interrelated activities that are conducted in a systematic manner by a group of agents to achieve a predefined end.

  • Stage: each subprocess in the final flowchart.

  • Operation: each of the activities or steps that make up a stage.

  • Hazard: an agent with the intrinsic potential to injure the health of the healthcare worker15. These agents are classified according to their cha racteristics:

    • - Physical hazard: objects or fragments of objects that may injure the worker.

    • - Biohazard: any type of microorganism from a patient that, either by direct or indirect contact with tissues or fluids, can cause an infection in healthcare workers.

    • - Chemical hazard: a chemical agent (HD) that due to its intrinsic toxi city can injure the personnel handling it.

  • Risk: the possibility of a worker experiencing a specific injury due to exposure to a hazard15. These risks are categorized as follows:

  • Physical risk: cuts from glass and other materials, puncture wounds from sharp objects, etc.

  • Biological risk: parenteral exposure to infectious agents (i.e. via puncture wounds after administration of a HD to an infected patient).

  • Chemical risk: exposure to a HD by inhalation, through the skin or mucous membranes, by contact with eyes, ingestion, and via paren teral routes.

Degree of consensus

Documentary techniques were used to analyse any stages over which there was disagreement until a 100% consensus level was reached.


The experts had an average of 22 ± 3.17 years of experience (median: 25.50 years; range: 8-28 years). In all cases, the degree of consensus on the objective criteria of choice was 100%. Table 1 shows the characteristics of the experts who comprised the group.

Table 1. Characteristics of the Members of the Expert Group (n = 6) 

Flowchart and HD management chart

Based on the expert consensus, we first designed the general outline of the process (Figure 1), which facilitated the development of the global process (Figure 2). Figure 2 shows all the stages that comprise the HD traceability management procedure in hospital pharmacy services, which would allow its monitoring and reproducibility.

Each stage was represented in a table (Table 2) to systematize and facilitate the understanding of the results. The following variables were coded for each stage of the process: stage, operation and operation number (i.e. the number that appears in each of the operations shown in the flowchart and facilitates their identification in the different documents), potential hazard (i.e. yes/no), type of hazard identified (i.e. chemical and physical), and HD exposure routes (skin and mucous membranes, ingestion, ocular, and injection).

Figure 1. Hazardous drug (hd) handling in hospital pharmacy service. 

Figure 2. Hazardous drugs (HD) handling in hospital pharmacy services - global process (1/2). 

Table 2. Risk management chart by stage 

Number that identifies each of the operations in the flowchart and facilitates its identification in the table

††see flowchart.

1Operation 10 will only be conducted if the person responsible for transporting the HDs from the general store to the clean rooms did not previously wear PPEs in the storage area; 2 Handwashing usually consists of disinfecting them with antiseptic solution when staying in the clean rooms because the work in them has not been completed. If the clean room is vacated, handwashing is done with soap and water; 3 PPEs used for processing will vary depending on the type of HD prepared (sterile or non-sterile); 4 Needles are required when preparing pharmaceutical forms from HDs contained in ampoules; 5 modify whole solid forms: split, cut, crush tablets, open capsules; 6 The removal of PPEs is conducted gradually, while passing through rooms with different degrees of environmental quality, following the standardized work procedure established.BSC, biological safety cabinet; HD, hazardous drug; IM, intramuscular; IT, intrathecal; IV, intravenous; PPE, personal protective equipment; SC, subcutaneous.

In total, 42 operations were established corresponding to the four stages of the handling process conducted in hospital pharmacy services: recep tion and bulk storage (17 operations (40.5%)); preparation (19 operations (45.2%)); drug storage (5 operations (12%)); and dispensing (1 operation (2.4%)).

Determination of potential hazards

Table 2 shows that 22 operations (52.4%) were associated with some type of hazard. These hazards were distributed as follows: physical hazard (12 operations (28.6%); and chemical hazard (22 operations (52.4%)). No biological hazard was identified (see Table 2).

Degree of consensus

The degree of final consensus among the experts was 100% for all stages, operations, and hazards identified. However, the reception and bulk storage stage was the area that caused the greatest initial differences of opinion during its development. In cases of disagreement, the available scientific evidence was reviewed until the group reached a level of agree ment of 100%.


The scientific literature has investigated and discussed in detail the health risks of handling HDs, regarding which there is increasing concern from the point of view of occupational health23.

The objective of the present study was to identify and analyse the theoretical hazards and risks of HDs in the HD logistics chain in hospital pharmacy services as the initial phase of a risk assessment. This objective required detailed knowledge of the entire logistics chain and its stages. The development of flowcharts played a key role in achieving this objec tive. As Ramos-Merino et al.24 indicated, flowcharts condense a large amount of information in a small space, visually represent the flow of the activities involved, and facilitate the rapid and efficient understanding of processes.

The main differences of opinion between the experts concerned the reception and bulk storage stage. Although this stage has been less ad dressed in the literature, it is the one in which there is the greatest variability in care practice, mainly due to the limited human resources, materials, and facilities available in each health centre. Nevertheless, after combining the opinions of the experts with the scientific evidence, a 100% consensus level was reached

Detailed study of the general process flowchart showed that almost half of the operations were concentrated in the preparation stage. This observation is unsurprising, given the heterogeneous catalogue of HDs that are currently prepared in pharmacy services (e.g. infusion bags, syringes, infusion pumps, topical forms, solid and liquid oral forms, and eye drops). Furthermore, in recent years, these types of processes have become more complex due to the need to improve the management of critical aspects that influence the safety of health personnel, patients, and the drugs themselves. This aspect explains the multiple control and protection operations during the preparation stage (i.e. operations 19, 23, 24, 25, 26, 28, and 32 (see Table 2 and Figure 2), as well as the use of sophisticated devices and equipment that reduce to the greatest extent possible contamination of the work area and environment, thereby ensuring worker safety.

The main risk inherent to the use of HDs is chemical risk, which is due to their intrinsic characteristics of carcinogenicity, teratogenicity, genotoxicity, reproductive or developmental toxicity, or organ toxicity at low doses. However, physical hazards are also an issue because sharp and pointed objects (e.g. glass recipients containing the HD, needles used in their pre paration) may be handled (i.e. operations 2, 4-7, 11-13, 20, 21, 27, and 29 (see Table 2). No biological hazards were identified, because there is no direct contact with patients or their fluids during the stages of the process conducted in the pharmacy services.

However, although physical injury may occur (e.g. cuts from glass bottles or glass fragments, or puncture wounds from needles), it should be noted that in practice this type of risk has been greatly minimized by the increa sed use of devices and equipment without needles, luer-lock connections, and the widespread use of HD containers made of polyolefin-type plastic. Currently, the use of glass is uncommon and has been relegated to specific situations in which there are incompatibilities between plastics and HDs14.

Given the magnitude of the problem, it is unsurprising that in recent years several governmental and non-governmental organizations, scientific socie ties, and expert panels have encouraged health organization managers to conduct assessments of the risks associated with the HD circuit16,18,23,25 26-27. In any case, the first step in improving occupational safety is to identify hazards.

Although this study is useful as a basis for future projects, it has several limitations. The first of these is related to the selection of the experts. It would have been desirable and enriching to have had available the opinions of other types of expert, such as occupational risk specialists, preventionists, or occupational health technicians (due to their high level of knowledge in the field), as well as pharmacy nurses or technicians (because they work directly in these areas). However, this could not be achieved due to high workloads and the absence of incentives in the development of this study. Nevertheless, it should be noted that this study represents the initial phase of the identification and description of the process: that is, it is the preliminary phase of a risk analysis which will include the opinions of a wider range of experts. A further limitation is that the description of the process and the identification of hazards was based on the healthcare practices of two hospitals and on theoretical knowledge, concerning which there is a lack of solid evidence. The latter aspect is due to both the lack of published material on adverse events that would allow the identification of hazards, as well as the great heterogenicity of internationally published guidelines19, thus reducing the external validity and applicability of this study in other settings. However, the model obtained in this study should be highly reproducible given that it was based on the high level of knowledge of the participants in HD handling and the systematic review conducted as a preliminary to the expert consensus. In any case, risk analysis is a dynamic process that has to undergo periodical reassessment based on any nonconformities obtai ned, such that any bias derived from the subjectivity of the participating experts can be corrected in the future.

Based on the foregoing, we suggest that HDs should be integrated within a standardized management system to improve the safety of patients and health workers, while maximizing resource efficiency and minimizing procedural incidents. Such a system would make it possible to establish a global system with fully characterized stages that would guarantee the qua lity and safety of the HD handling process in pharmacy services.

Once hazards have been identified, risk assessment should be imple mented using a systematic and preventive methodology to estimate the risk and severity of any adverse event.


Expert group

Carmina Wanden-Bergue Lozano: Associate physician of the Home Hospitalization Unit, Hospital General Universitario de Alicante, Spain. Ex tensive experience in risk assessment. She has participated in competitive projects on Hazard Analysis and Critical Control Points (HACCP) addres sing parenteral nutrient mixtures (PI13/00464), which has already been widely disseminated at an international level and led to the registration of patent 09/2014/3148.

Javier Sanz Valero: Public Health Pharmacist. Official Regulatory Con trol Officer of Public Health of the Department of Health of the Valencian Government. He was recently Auditor of Risk Analysis Systems, with proven experience in process quality audits through the application of risk analysis.

Scientific researcher of the Escuela Nacional de Medicina del Trabajo del Instituto de Salud Carlos III.

Associate Professor at the Universidad Miguel Hernández, Departamen to de Salud Pública e Historia de la Ciencia.

María Ángeles Bernabeu Martínez: Hospital Pharmacist. Primary care pharmacist, Departamento Hospital General Universitario de Alicante, Spain.

Pedro García Salom: Hospital Pharmacist. Section Head. Hospital Ge neral Universitario de Alicante, Spain.

Coordinator of the Working Group on Hazardous Drugs of the Ministry of Health.

Member of the Expert Group of the Ministry of Health, Social Services, and Equality for the development of the "Good Practice Guide for Drug Preparation in Pharmacy Services".

Amparo Burgos San José: Associate hospital pharmacist. Hospital General Universitario de Alicante, Spain Head of the Oncohematology Pharmacy Unit. BCOPS (Board-Certified Oncology Pharmacy Specialist).

Andrés Navarro Ruiz: Hospital Pharmacist. Head of Service. Hospital General Universitario de Elche.

Associate Professor at the Universidad Miguel Hernández. Masters in Pharmacovigilance and Post-authorization Studies. Masters in Pharmaceu tical Care.


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Funding: This work was supported by the Instituto de Salud Carlos III de Madrid, Spain through the Health Research Project reference number PI16/00788.

Contribution to the scientific literature:

Propose a taxonomy of risks arising from exposure to hazardous drugs in the setting of pharmacy services.

This study will allow hospitals to analyse critical points and establish preventive and corrective measures.

How to cite this paper: Bernabeu-Martínez MA, García-Salom P, Burgos-San José A, Navarro-Ruiz A, Sanz-Valero J, Wanden-Berghe C. Consensus to identify the dangerous drugs risks in hospital pharmacy services. Farm Hosp. 2020;44(2):51-61.

Received: June 14, 2019; Accepted: September 23, 2019

Autor para correspondencia. María Ángeles Bernabeu Martínez Hospital General Universitario de Alicante C/ Pintor Baeza s/n. 03010 Alicante, (Spain). Correo electrónico:

Conflicts of interest

No conflict of interests.

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