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Introduction
In 2004, the National Institute for Occupational Safety and Health (NIOSH) defined the term Hazardous Drug (HD)1 as those medications presenting one or more of the following risk criteria in humans: carcinogenicity, tetarogenicity or other toxicity for development, reproductive toxicity, organ toxicity at low doses, genotoxicity; and new medications with structure and toxicity profiles similar to existing medications already classified as hazardous according to the previous criteria.
At the same time as the HD definition from 20041, the NIOSH published a list of HDs, which was updated in 20102, 20123, 20144 and the draft for the 2016 update was being prepared at the time of writing this document5, differentiating the risk of those drugs included in three groups (Table 1).
The effects of HDs on health, both therapeutic and side effects, are justified in patients because there is a favourable benefit / risk balance; however, exposure in healthcare staff must be reduced as much as possible6. The safety and health of the staff is a key matter in any healthcare centre; therefore, it has been necessary to determine some recommendations for handling those HDs that pose a risk for the healthcare staff handling said medications.
Faced with the lack of specific regulations in Spain for handling HDs, and the existence of publications warning about the health risks associated with certain medications, there has been a social alarm that justifies the fast preparation and dissemination of a working procedure for handling hazardous drugs, in order to minimize risks for the healthcare staff. Following the criteria scientifically established by organizations with acknowledged prestige, we have selected the documents published by the NIOSH in 20144, and its 2016 update5, and by the National Institute of Occupational Safety and Hygiene (INSHT): “Hazardous Drugs: Prevention measures for their preparation and administration”, as well as the consensus document “Safety for patient and healthcare staff in the preparation and administration of hazardous drugs”7, as the basis for the development of a working procedure for handling HDs in our healthcare centre, with the aim to facilitate a method of work that will observe the safety and health of the staff within a safe setting.
Objectives
To develop a safe working procedure for the staff in the Hospital Intermutual de Levante (HIL) in the different areas associated with handling HDs, including any protection equipment required, with the aim to reduce risk and minimize exposure as much as possible.
To disseminate the current information about the risk for workers derived by handling HDs and their waste material in all work areas and positions that might be affected by said handling.
To ensure safety for the staff, the working environment, and the medication.
Materials and method
The working procedure was developed in six stages:
Definition of Hazardous Drug (HD).
Definition and identification of procedures and preparation of general recommendations for the selection and handling of HDs. The procedures involved in HD procedures were defined and identified, and a bibliographic review was conducted about the protection measures for the handler at each one of these procedures, based on the recommendations by the main international associations dealing with HD handling.
Detection, selection and implementation of specific handling recommendations during the preparation and administration of those HDs included in the ho care pital formulary8. The information about the molecules included in the “NIOSH list of antineoplastic and other hazardous drugs in healthcare settings, 2014”4 and “Proposed additions to the NIOSH 2016 hazardous drugs list”5 was compared with the list of medications included in our hospital formulary8. In order to determine the specific handling recommendations (infrastructures and individual protection equipment (IPE) for each HD, the following were taken into account: their category within the NIOSH lists (1, 2 or 3), their formulation, way of administration, and place and conditions of preparation and administration. Besides, therapeutic alternatives with lower handling risks were assessed for each HD.
Classification of risk during preparation / administration and development of a system for identification. In order to facilitate the identification and homogeneity of HD handling, those HDs that shared handling measures during their preparation and administration were grouped into categories.
Information and training for professionals.
Implementation of measures for identification and guidelines for action.
Results
Stage a) Definition of Hazardous Drug (HD).
In terms of occupational exposure, Hazardous Drugs were defined as: those agents that, due to their inherent toxicity, represent a risk for the healthcare staff handling them. The risk posed by these medications is understood in terms of chemical risk, specifically, associated with the carcinogenic, teratogenic, genotoxic, toxic for the reproductive process or for a specific organ at low doses, or by being a new drug similar to those with this type of risks. In this sense, the following rules apply to HDs: protection rules for workers associated with the exposure to chemical agents (RD 374/2001)9, carcinogenic agents (RD 665/1997)10 and their subsequent modification (RD 349/2003)11, and the 2004/37/CE directive12 about protection against the risks of exposure to carcinogenic or mutagenic agents during work.
Stage b) Definition and identification of procedures and preparation of general recommendations for the selection and handling of HDs
The “potentially hazardous” procedures, activities, operations, equipment or products (article 4.5 of the Law for Prevention of Occupational Risks)13 will be defined as those that, in the absence of specific preventive measures, will pose risks for the safety and health of the staff developing or using them.
Six procedures involved in HD handling were identified: selection, reception, transportation and distribution, preparation, administration, and waste management.
The following HD handling recommendations were reviewed: by the NIOSH4, INSHT6, Oncology Nursing Society (ONS)14, American Society of Health-System Pharmacists (ASHP)15, National School of Occupational Medicine in the Instituto de Salud Carlos III (ISC)16, U.S. Pharmacopoeia (USP)17 and International Society of Oncology Pharmacy Practitioners (ISOPP)18; and based on these, general recommendations for HD handling were prepared for each of the procedures detected (Appendix 1)19,20.
Stage c) Detection, selection and implementation of specific handling recommendations for those HDs included in the hospital formulary
Twenty-nine (29) medications included in the hospital formulary8 were identified as molecules classified as hazardous by the “NIOSH list of antineoplastic and other hazardous drugs in healthcare settings, 2014”4 and “Proposed additions to the NIOSH 2016 hazardous drugs list”5. Besides, even though acenocoumarol was not included in the NIOSH lists, it was considered a HD given its similarity with warfarin (NIOSH List 3). Therefore, 30 medications included in the hospital formulary were finally identified as HDs. According to their level of risk, none was included in List 1 (antineoplastic drugs), 12 were from List 2 (non-antineoplastic drugs that meet at least one criterion for hazardous drugs), and 18 were from List 3 (drugs that pose a reproductive risk to men and women who are actively trying to conceive and women who are pregnant or breast feeding, but that present no risk for the rest of the staff).
A pharmaceutical alternative with lower risk in handling was found for six of the 30 HDs included in the hospital formulary. Five of these six HD were oral solid formulations that could be split or crushed for their administration to patients with swallowing problems; therefore, instead of splitting or crushing, it was decided to prepare oral liquid formulations as magistral formula in a biological safety cabinet (BSC), to simplify preparation and administration and reduce handler exposure to the drug. The remaining HD was marketed in vials, so it was decided to purchase it as magistral formula in vials in order to minimize exposure. Thus, the final list included 36 HDs.
Finally, based on the classification of each HD in the NIOSH lists4,5, their formulation, and the Technical Document by the INSHT: “Hazardous Drugs: Prevention measures for their preparation and administration”6, a list was prepared with all HDs and the specific handling recommendations for each one of them (Appendix 2).
Stage d) Classification of risk during preparation/administration, and development of a system for identification
According to the specific measures for handling each HD included in the list of specific recommendations (Appendix 2), these were classified into four categories from lower to higher risk at handling during preparation and administration. In order to simplify HD handling, common measures were established for each category. In the case of those medications with different protection measures according to the reproductive risk for the staff, it was decided to implement the protection measures for the group of professionals with the highest level of protection. In order to differentiate each category, an identification system was implemented, based on a colour code from lower to higher level of protection during preparation and administration (green, yellow, blue and red) (Table 2). The number of HDs included in each category was: 16 in Green, 10 in Yellow, 8 in Blue and 2 in Red (Appendix 3).
Stage e) Information and training for professionals
With general application, and according to Articles 18 and 19 of the Law for Prevention of Occupational Risks13, workers must receive adequate information and training about the risks derived of the presence of any hazardous chemical agent present in their working place, as well as about the prevention and protection measures to be adopted. In particular, the training of the staff working with hazardous drugs is a key aspect to prevent occupational risks.
Therefore, all professionals involved in handling medications were informed through a Conference for the Safe Use of Medications that was publicized externally and given by the Pharmacy Unit and the Occupational Risk Prevention Unit, with the participation of the Occupational Risk Prevention Unit from the Conselleria de Sanitat Universal y Salut Pública of the Community of Valencia.
Moreover, fortnightly internal sessions were given to the entire healthcare staff, in order to present the code of identification by colours; all the required materials for fast reference were provided, and there was training on the Procedure for “Safe Drug Handling”.
In the same manner, the PPEs required were provided in all grounds and departments in which MPs could be handled.
Stage f) Implementation of measures for identification and guidelines for action
Reception and storage: HD labelling by colours based on their category in the classification, both in their packaging (for those HDs distributed in their original package) and in their primary preparation.
Distribution: HDs in the Green and Yellow categories will be normally distributed with the label assigned at reception. The drugs in red and blue categories will be prepared at the Pharmacy Unit and will be identified in the secondary conditioning with red and blue labels, respectively.
Preparation and Administration: Based on the colour code recommendations (Table 2).
Discussion
The potential exposure to HDs in each procedure where these are present will depend on various factors19:
Intrinsic risk posed by the medication due to its carcinogenic, teratogenic, or genotoxic potential, as well as reproductive toxicity and organ toxicity at low doses.
Sensitivity of the handler: allergies, pregnancy, breastfeeding, reproductive age.
Level of exposure: Penetration or absorption ability of the medication, concentration, amount, handling duration and frequency, type of activity, place, and associated risk of exposure (formulation).
Structure: human resources (education and training, number of handlers), premises (design and technical specifications, availability and type of BSC), use of closed system drug transfer devices (CSTDs) for preparation and administration, and availability of automatic systems.
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Use of prevention measures: technical measures (BSC), CSTDs, automatic systems, organization measures (cleaning procedures, actions for spillage and maintenance, waste management and handling techniques) and secondary prevention measures (SPMs), that should feature some minimum characteristics19 (Table 3).
Therefore, staff protection must be adapted to each one of these activities and drug formulations, because the precautions to be taken are different in each case. For example, as stated in the NIOSH document from 20144, “in situations such as capsule opening, or tablet splitting or crushing, when there are no extraction cabinets, safety cabinets or isolators, at least double gloves should be used, as well as mask, lab coat, and working surface protection”. Besides, as this list included a great variability of medications, from high-risk cytotoxic agents to medications that could only affect fertile-age staff to a lower degree, the actions to be determined should not be general; instead, there should be a case-by-case analysis, and therefore the following procedure should only be used as a reference.
This means that the list of medications stated in the publication by the NIOSH4,5 can be used as a reference in order to determine specific measures for managing each HD, and each centre should adapt it to its own situation and needs, as well as keep it updated with the new medications, taking into account the recommendations by their manufacturers.
However, given the large number of HDs included in the list, it will be impossible to implement a procedure to ensure the correct and safe manipulation of each HD in the different procedures where it appears.
Therefore, a simplification is necessary in order to ensure an adequate identification. As a general rule, HDs should be identified during the process of their use, including the whole chain, from selection, reception, re-packaging, storage, distribution, preparation, administration, and waste management; and medications should be classified in order to implement common measures of handling in each procedure, to ensure a correct and safe handling of each HD.
Conclusion
It has been impossible to determine clearly he toxic effects at long-term of exposure to these drugs, but there is evidence of their danger, the potential occupational risk represented by their handling, and the consequences derived. Therefore, it is imperative to adopt measures that will help to reduce this exposure, and guarantee optimal working conditions. In this sense, the most adequate activity will be prevention.
Different incidents associated with HDs have forced hospitals to prepare working procedures with higher or lower complexity or difficult to understand and follow by the staff. The classification and categorization designed for our working procedure has simplified to a great extent the identification and handling of HDS included in the hospital formulary, so that any healthcare professional will know how to act adequately and safely in any procedure involving HDs.
Moreover, the Hospital Administration should regulate the hazard level of medications through visual codes or symbols, in a way similar to the one stated in this procedure. This will equally become a useful tool within the policies for occupational risk prevention in any healthcare centre.
In conclusion, the development and implementation of specific work procedures for the safe handling of drugs will allow hospital authorities to meet effectively all legal duties in prevention matters, as well as to provide staff with an adequate setting to avoid the potential risk posed by some medications.
