Abstract
Objective: To develop a safety working procedure for the employees in the Intermutual Hospital de Levante (HIL) in those areas of activity that deal with the handling of hazardous drugs (MP).
Methods: The procedure was developed in six phases: 1) hazard definition; 2) definition and identification of processes and development of general correct work practices about hazardous drugs’ selection and special handling; 3) detection, selection and set of specific recommendations to handle with hazardous drugs during the processes of preparation and administration included in the hospital GFT; 4) categorization of risk during the preparation/administration and development of an identification system; 5) information and training of professionals; 6) implementation of the identification measures and prevention guidelines.
Results: Six processes were detected handling HD. During those processes, thirty HD were identified included in the hospital GFT and a safer alternative was found for 6 of them. The HD were classified into 4 risk categories based on those measures to be taken during the preparation and administration of each of them.
Conclusions: The development and implementation of specific safety-work processes dealing with medication handling, allows hospital managers to accomplish effectively with their legal obligations about the area of prevention and provides health-care professional staff with the adequate techniques and safety equipment to avoid possible dangers and risks of some drugs.
KEYWORDS: Drugs, Hazardous, Use, Procedure, Management, Risk, Manipulative, Professional, Health-workers.
Resumen
Objetivo: Desarrollar un procedimiento de trabajo seguro para los trabajadores del Hospital Intermutual de Levante (HIL) en las distintas áreas de actuación relacionadas con la manipulación de medicamentos peligrosos (MP).
Métodos: El procedimiento se desarrolló en seis fases: 1) definición de medicamento peligroso; 2) definición e identificación de procesos y elaboración de recomendaciones generales sobre selección y manejo de MP; 3) detección, selección y establecimiento de recomendaciones específicas para el manejo durante la preparación y la administración de los MP incluidos en la GFT del hospital; 4) categorización del riesgo durante la preparación/administración y desarrollo de un sistema de identificación; 5) información y formación a los profesionales; 6) implantación de las medidas de identificación y las pautas de actuación.
Resultados: Se detectaron seis procesos implicados en el manejo de MP. Se identificaron 30 MP incluidos en la GFT del hospital y se encontró una alternativa más segura para seis de ellos. Los MP se clasificaron en cuatro categorías de riesgo en función de las medidas a adoptar durante la preparación y administración de cada uno de ellos.
Conclusiones: El desarrollo e implementación de procedimientos de trabajo específicos para el manejo seguro de medicamentos permite a los responsables de un hospital cumplir de forma efectiva con las obligaciones legales en materia preventiva, así como proporcionar a los trabajadores un medio adecuado para evitar la posible peligrosidad de algunos medicamentos.
PALABRAS CLAVE: Medicamentos, Peligrosos, Procedimiento, Manejo, Seguro, Riesgo, Manipulador, Profesional, Trabajadores sanitarios.
ORIGINALES
Safe procedure development to manage hazardous drugs in the workplace
Grupo Aula Médica
Received: 03 August 2016
Accepted: 21 November 2016
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).
Level of risk posed by HDs.
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.
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.
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 hospital 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.
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.
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.
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).
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).
Color code based on the specific management recommendations during the preparation and administration of the MP
The number between brackets corresponds to the number of the NIOSH list in which this medication is included. Acenocoumarol by similarity with warfarin (not included in NIOSH). List 1: Antineoplastic or cytostatic agents. List 2: Non-antineoplastic medications that meet one or more NIOSH criteria to be considered of risk. List 3: Non-antineoplastic medications with effects on reproduction, and that can affect men and women who are trying actively to conceive, and pregnant or breastfeeding women, but that don’t represent a risk for the rest of the staff. 1 Whenever possible, the original blister will be kept at re-packaging. 2 Staff at reproductive risk: men and women who are actively trying to conceive, and pregnant or breastfeeding women. 3 For treatments prescribed continuously and that need to be prepared, this will be done at the Pharmacy Unit (PU) in CSBIIB2. Exceptional treatmetns will be prepared according to the protection measures already mentioned and, in case of persistence, their preparation will be similarly assumed by the PU. MG: Magistral Formula; Class II B2 BSC: Class II Type B2 Biological Safety Cabinet; CLDT: Closed System for Drug Transfer.
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.
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).
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.
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).
Minimum characteristics of SPMs19
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, repackaging, 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.
Conclusions
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.
Table 4, Table 5 and Table 6 detail the recommendations for the SPMs to be used in different activities.
Recommendations about the equipment to be used according to specific tasks in handling non-sterile hazardous drugs
(*) It is considered that there is Risk of Splashing in the following situations: there is risk of resistance by the patient, administration diluted in liquid, and administration through feeding tube.
Recommendations about the equipment to be used according to specific tasks in handling sterile hazardous drugs
(*) It is considered that there is Risk of Splashing in the following situations: there is risk of resistance by the patient, administration diluted in liquid, and administration through feeding tube.
Individual Protection Equipment. Recommended SPMs for different handling of hazardous drugs
Adapted from Source “Guía de Buenas Prácticas para Trabajadores Profesionalmente Expuestos a Agentes Citostáticos” (“Good Practice Guidelines for Workers Professionally Exposed to Cytostatic Agents”) (Escuela Nacional de Medicina del Trabajo. Instituto de Salud Carlos III. Ministerio de Economía y Competitividad. Asociación Madrileña de Medicina del Trabajo en el Ámbito Sanitario (AMMTAS) 2014). Source: “Monografías de Farmacia Hospitalaria y Atención Primaria. Medicamentos Peligrosos.” Issue 6. Year 2016.
1. Selection Criteria
Among other criteria, the following should be studied:
To choose those marketed formulations with contents better adapted to usual dosing, with the aim to minimize handling.
To choose the most adequate and easy-to-use strength (1, 2, 5, 10, 25 mg/ml).
Not mixing / preparing at the same time formulations of the same medication with different strengths.
To choose, if possible, and in case of hazardous drug, what appears in Appendix 1a and Appendix 1b, which are basically formulations with a design that guarantee their low external contamination. Thus, it is better to select:
Vials vs. ampoules.
Formulations as solution for immediate use vs. lyophilized formulations.
Drugs packaged in breakage-proof polypropylene vs. glass.
Certain compounds already pre-charged in syringes ready for administration.
To select among marketed formulations those with a more efficient sealing of the vial after puncture, because if there is an incomplete sealing when the needle is removed, there will be an increased risk of environmental contamination.
The presence or not of preservatives will affect the use-by date of the solution from its first use; and therefore it will determine, together with its physicochemical stability, the validity of the remaining fractions after preparing one treatment.
2. Reception and storage
All medications are received at the Pharmacy Unit in the Hospital Intermutual de Levante.
It is recommended to wear synthetic globes (nitrile, polyurethane, neoprene) for the manipulation and distribution of drugs in storage.
When opening the packaging of these drugs, attention should be paid to the presence of any broken packaging; in this case, the person must get adequate protection and follow the rules of action established against spillage.
Hazardous drugs must be stored with caution, in order to avoid any packaging breakage.
The fact that some drugs require low temperature for their storage must be taken into account (there is cold storage for these medications), and/or protection from the light (these must be kept in their original packaging).
Table 4, Table 5 and Table 6 show the recommendations for SPMs to be used in different activities.
3. Preparation
HDs must be prepared by authorized staff, and as far as possible this preparation should be centralized in the Pharmacy Unit.
In the working areas where medications are administered:
The staff must not eat, drink, chew gum or store food.
The staff must not use makeup or other cosmetic products that could lead to prolonged exposure in case of contamination.
Measures for adequate hand washing will be implemented, as well as working in a sterile area (if necessary), and the adequate SPMs will be used if necessary.
Any members of staff of reproductive age, and actively trying to conceive, who are handling drugs from List 3, must adopt all prevention measures recommended in this procedure.
This type of drugs might have restrictions for those professionals in the following situations:
Pregnant or breastfeeding women.
Staff considered at high-risk (with previous history of miscarriages or congenital malformations, previous treatments with cytostatic agents or ionizing radiations) and cutaneous allergies.
Fertile men and women actively trying to conceive.
Any of these situations should be reported to the Unit for Occupational Risk Prevention.
The number of persons handling HDs should be reduced as much as possible, through organization measures and the use of preparations that require the lowest level of handling.
4. Transportation and distribution
Transportation must be conducted in such a way as to avoid breakages or spillages.
No mechanical transportation systems will be used, such as pneumatic tubes.
In case any drug is not administered, it will be returned to the Pharmacy Unit through the same procedure and in the same packaging as it was delivered to the place of administration.
5. HD administration
Administration will include all techniques required for administering the treatment, regardless of its way of administration; the most frequently used are: intravenous, subcutaneous (SC), topical, intramuscular (IM) and oral.
Administration will be conducted following the recommendations in the product specifications for each drug, and always according to the Standard Operating Procedures (SOPs) or HIL Guidelines.
Oral Formulations
The selection of formulation will be conducted by prioritizing whole units (tablets, pills and/or capsules) and oral suspensions. If fragmented formulations are required, these must be prepared at the Pharmacy Unit.
When oral formulations are handled, direct contact with the drug should be avoided (see Section on SPMs).
When the medication is supplied in a package, or even packaged in single doses, and it is self-administered by the patient, it will ONLY be handled with single gloves, without any other measure required.
Topical Application
Creams or other topical formulations must be applied with the SPMs stated. During this technique, handling must be restricted to the lower extent, using a spatula or other application products in order to avoid contact with the product.
Subcutaneous (SC) and Intramuscular (IM) Administration
It will be preferred to prescribe drugs which are pre-charged and purged with closed drug transfer devices systems. In those cases where purge is required, sterile gauze will be used, soaked in 70º alcohol, to prevent sprays and surface contamination.
A cloth with an absorbent upper side and a water-proof lower side should be placed under the administration line, with the aim to avoid contamination of bedclothes or the administration chair, in case of spillage.
Both in SC and IM administration, the needle won’t be unattached to the syringe at any point; the connections must be luerlock to prevent any accidental disconnection, and discarded as one single piece in the adequate container. After the injection, extraction will be conducted with gauze soaked in 70º alcohol, to prevent any drug reflux or dripping.
During administration, individual protection equipment must be used (see Section on SPMs). Eye and respiratory protection will only be necessary if there is a reasonable risk of splashing, or if the patient’s conditions could cause a potential accidental disconnection.
Intravenous Administration
It is recommended to implement closed drug transfer devices systems. This task must be conducted at preparation, so that no connection or disconnection are required during drug administration.
The system will be disposed of as one single piece in the specific container, the drugs used must not be disconnected.
The staff involved in this technique should be trained to ensure an adequate use of closed systems, in order to achieve an optimal performance and reduce to the lowest extent any risk of dripping, spillage, or spray.
During administration, individual protection equipment must be used (see Section on SPMs). Eye and respiratory protection will only be necessary if there is a reasonable risk of splashing, or if the patient’s conditions could cause a potential accidental disconnection.
Action in case of accidental spillage and exposures
Spillage
The worker must be protected with a waterproof lab coat, goggles or screen with lateral protection, shoe covers, and 2 pairs of gloves, one made of thick rubber and another one of non-powdered latex. In case the spillage has occurred outside the BSC, a FFP3-type mask for respiratory protection will also be used. These will be worn in the following order: shoe covers, lab coat, mask, first pair of gloves over the coat, second pair of gloves, and goggles or screen.
The spillage will be absorbed with cellulose or an absorbing cloth (dry if liquids and wet if dry powder) before proceeding to cleaning it. If there are rests of glass, these will never be collected with the hand, but with tweezers (or a collecting brush), and they will be placed in a small rigid container for sharp / cutting objects.
The dry surface must be cleaned afterwards with cellulose soaked in 70º alcohol. The area will be cleaned 3 times with soap and water or detergent cleaner / bleach, finally rinsing it with plenty of water, always going from the less contaminated to the most contaminated areas.
The protection equipment must be removed in this order: first pair of gloves, shoe covers, second pair of gloves, mask, lab coat and goggles. Everything should be discarded, except if eye-glasses are used; tweezers can be reused after being carefully washed with soap and water (hands should be protected with a clean pair of gloves in order to conduct this procedure).
All waste generated, as well as the materials used, will be treated as contaminated materials at the time of disposal.
Accidental exposure
If there is direct contact of the drug with the skin: The affected area will be immediately washed with soap and water, during approximately 10 minutes. If the skin appears irritated, it should be examined by a specialist.
If the drug splashes the eyes: rinse the affected eye with water or isotonic solution during at least 15 minutes, and then consult the specialist.
In case of accidental ingestion, it is necessary to see a doctor immediately.
In any of these cases, it will be reported to the Occupational Health area of the Prevention Unit to enable the specific pharmacovigilance.
7. Waste management
Drug waste must be treated in the Group III or Group IV containers, according to the current procedure for waste management.
8. Action by the Prevention Unit
Potential exposure to HDs in each of the activities described will depend on the set of preventive measures adopted; therefore, the potential exposure and its level must be established according to the risk evaluation conducted in each specific case.
The extent of the risk will depend on:
The toxicity inherent to each medication.
The level of exposure, associated with:
Workload.
Handling conditions.
Environmental protection.
Protection materials.
Handling technique, involving procedures, training and periodical assessment.
Time of exposure.
Stage of the process. There is higher risk in preparation and accidental spillage, though protection measures should include all stages of the process.
Characteristics of the handler (reproductive age, simultaneous exposure to other agents, etc.).
Another important aspect to be taken into account is the potential ways of penetration of these substances into the body, which are:
Inhalation of sprays and micro-drops emitted during the preparation of the hazardous drug solutions for administration, when vials are broken, while purging the system, etc.
Through direct contact, by penetration of the medication through the skin or mucosa.
Orally: ingestion of food and drinks, contaminated cigarettes.
Parenterally: through direct introduction of the medication by accidental needle sticks or cuts caused by vial breakage.
9. Individual protection equipment
The worker exposed should be qualified, aware of the risks taken if exposed to these drugs without an adequate protection, as well as of the conditions required for patient safety.
Thee requirements about the use of Individual Protection Equipment according to each medication have been stated in previous sections of this protocol (Appendix 2 and Appendix 3).
The SPM specifications for each activity are not the object of this document.
10. Information and training for the staff
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 staff working with biohazardous drugs is a key aspect to prevent occupational risks.
* Preparation of liquid oral formulations refers to re-dosing (charging the syringe), not to the production of the medication. ** Whenever possible, the original blister will be kept at re-packaging. *** Use preferably the liquid oral formulation. If no liquid oral formulation is available, splitting will be done at the Pharmacy Unit in a Class II B2 BSC. MF: Magistral Formula; ORPU: Occupational Risk Prevention Unit; Class II B2 BSC: Class II Type B2 Biological Safety Cabinet. Since the display of this article is not in color, the words green, yellow, blue and red have been recorded in the tables below each medication. This color indicates the category of protection of that drug according to the color code from the lowest to the highest degree of protection during the preparation and administration (green, yellow, blue and red) as explained in the procedure described“.
There is a summary below of the Hazardous Drugs (HDs) included in the formulary of the HIL.
The number between brackets corresponds to the number of the NIOSH list in which this medication is included. Acenocoumarol by similarity with warfarin (not included in NIOSH) List 1: Antineoplastic or cytostatic agents. List 2: Non-antineoplastic medications that meet one or more NIOSH criteria to be considered of risk. List 3: Non-antineoplastic medications with effects on reproduction, and that can affect men and women who are trying actively to conceive, and pregnant or breastfeeding women, but that don’t represent a risk for the rest of the staff. 1 Whenever possible, the original blister will be kept at re-packaging 2 Staff at reproductive risk: men and women who are actively trying to conceive, and pregnant or breastfeeding women. 3 For treatments prescribed continuously and that need to be prepared, this will be done at the Pharmacy Unit (PU) in CSBIIB2. Exceptional treatmetns will be prepared according to the protection measures already mentioned and, in case of persistence, their preparation will be similarly assumed by the PU. MG: Magistral Formula; Class II B2 BSC: Class II Type B2 Biological Safety Cabinet; CLDT: Closed System for Drug Transfer. Since the display of this article is not in color, the words green, yellow, blue and red have been recorded in the tables below each medication. This color indicates the category of protection of that drug according to the color code from the lowest to the highest degree of protection during the preparation and administration (green, yellow, blue and red) as explained in the procedure described“
En la Tabla 4, Tabla 5 y Tabla 6 se detallan las recomendaciones de EPIs a utilizar en las diferentes actividades.
Recomendaciones de equipo a utilizar según tareas específicas en la manipulación de medicamentos peligrosos no estériles
(*) Se considera que existe riesgo de salpicadura en las siguientes situaciones: existe riesgo de resistencia por parte de paciente, administración desleída en líquido y administración por sonda de alimentación.
Recomendaciones del equipo a utilizar según tareas específicas en la manipulación de medicamentos peligrosos estériles
(*) Se considera que existe riesgo de salpicadura en las siguientes situaciones: existe riesgo de resistencia por parte de paciente, administración desleída en líquido y administración por sonda de alimentación.
Equipos de protección individual - EPI recomendados para las diferentes manipulaciones de Medicamentos Peligrosos.
Adaptación de Fuente Guía de Buenas Prácticas para Trabajadores Profesionalmente Expuestos a Agentes Citostáticos (Escuela Nacional de Medicina del Trabajo. Instituto de Salud Carlos III. Ministerio de Economía y Competitividad. Asociación Madrileña de Medicina del Trabajo en el Ámbito Sanitario (AMMTAS) 2014) Fuente: Monografías de Farmacia Hospitalaria y Atención Primaria. Medicamentos Peligrosos. Número 6. Año 2016.
1. Criterios de selección
Entre otros criterios, se deben estudiar los siguientes:
Elegir las presentaciones comerciales cuyo contenido se adapte mejor a las dosis habituales, con objeto de minimizar la manipulación.
Elegir la concentración más apropiada y de fácil manejo (1, 2, 5, 10, 25 mg/ml).
No mezclar/preparar al mismo tiempo presentaciones de un mismo medicamento con diferentes concentraciones.
Elegir, si es posible y en caso de fármaco peligroso lo indicado en el Apéndice 1a y Apéndice 1b, que básicamente son presentaciones cuyo diseño garantice la baja contaminación exterior de las mismas. De esta forma, son preferibles:
Los viales frente a las ampollas.
Las presentaciones en solución para uso inmediato frente a los liofilizados.
Las presentaciones con envase de polipropileno a prueba de rotura, frente al cristal.
Ciertos compuestos ya precargados en jeringas listas para la administración.
Seleccionar entre las presentaciones comerciales aquellas en las que el sellado del vial tras la punción sea más eficiente, ya que en el caso de que este sellado sea incompleto al retirar la aguja, el riesgo de contaminación ambiental aumenta.
La presencia o no de conservantes afecta a la caducidad de la solución a partir de su primera utilización y, por tanto, junto con la estabilidad físico-química, condiciona la validez de las fracciones sobrantes tras la preparación de un tratamiento.
2. Recepción y almacenaje
La recepción de todos los medicamentos, se realiza en el Servicio de Farmacia del Hospital Intermutual de Levante.
Se recomienda utilizar guantes sintéticos (nitrilo, poliuretano, neopreno) para la manipulación y distribución de medicamentos en almacén.
Al abrir los paquetes de estos medicamentos se prestará atención por si hubiera algún envase roto en cuyo caso la persona se protegerá adecuadamente y seguirá las normas de actuación establecidas frente a derrames.
El almacenamiento de los medicamentos peligrosos se realizará con precaución de modo que se eviten roturas de los envases.
Se tendrán en cuenta todos aquellos medicamentos que requieren bajas temperaturas para su conservación (se dispone de cámaras frigoríficas para estos medicamentos) y/o protección de la luz (se mantendrán en su envase original).
En la Tabla 4, Tabla 5 y Tabla 6 se detallan las recomendaciones de EPIs a utilizar en las diferentes actividades.
3. Preparación
La preparación de MP debe realizarse por personal autorizado y se centralizarán en la medida de lo posible en el Servicio de Farmacia.
En las áreas de trabajo donde se administren los medicamentos:
El personal no deberá comer, beber, masticar chicle ni almacenar alimentos.
El personal no utilizará maquillaje ni otros productos cosméticos que puedan provocar una exposición prolongada en caso de contaminación.
Se implementarán medidas de lavado de manos adecuado, trabajo en zona estéril (en caso necesario) y se utilizarán si es necesario los EPI adecuados, lavado de manos.
El personal que se encuentre en edad reproductiva y que esté intentando concebir de forma activa y manipule fármacos de la lista 3, deberá adoptar todas las medidas de prevención recomendadas en este procedimiento.
Este tipo de medicamentos pueden tener restricciones para los profesionales que se encuentren en las siguientes situaciones:
Mujeres embarazadas o en período de lactancia.
Personal considerado de alto riesgo (con antecedentes de abortos o malformaciones congénitas, tratamientos previos con citostáticos o radiaciones ionizantes) y alergias cutáneas.
Hombres y mujeres fértiles intentando concebir de forma activa.
Cualquiera de dichas situaciones se deberá comunicar al Servicio de prevención de riesgos laborales.
Debe reducirse al máximo el número de personas que manejan MP, mediante medidas organizativas y la utilización de preparaciones que requieran la menor manipulación posible.
4. Transporte y distribución
El transporte se debe realizar de forma que se eviten roturas o derrames.
No se emplearán sistemas mecánicos de transporte tipo tubos neumáticos.
En caso de que algún medicamento no se administre, se devolverá al Servicio de Farmacia por el mismo procedimiento y en el mismo envase que se entregó en el lugar de administración.
5. Administración de MP
La administración comprenderá todas las técnicas necesarias para la aplicación del tratamiento, independientemente de la vía de administración, siendo las más utilizadas la vía intravenosa, la vía subcutánea (SC), la vía tópica, la vía intramuscular (IM) y la vía oral.
La administración se realizará siguiendo las recomendaciones de las fichas técnicas de cada fármaco y siempre según los Procedimientos Normalizados de Trabajo (PNT) o Guías del HIL.
Formas orales
La elección de presentación se realizará priorizando las unidades completas (comprimidos, grageas y/o cápsulas) y las suspensiones orales. En el caso de precisar formas fragmentadas, estas deberán ser preparadas en el Servicio de Farmacia.
Cuando se manipulen formas orales, se debe evitar el contacto directo con el fármaco (ver apartado EPI).
Cuando el medicamento se suministre envasado o incluso envasado en unidosis y la administración sea por parte del propio enfermo ÚNICAMENTE se manipulará con guantes simples, no siendo necesaria ninguna otra medida.
Aplicación tópica
Las cremas u otras formas tópicas deben aplicarse con los EPI indicados. Durante la técnica se restringe la manipulación a lo mínimo posible, utilizando espátulas u otros productos de aplicación que eviten el contacto con el producto.
Administración subcutánea (SC) e intramuscular (IM)
Preferentemente se pautarán fármacos precargados y purgados con sistemas cerrados de transferencia. En el caso de precisar purgado se utilizará una gasa estéril empapada en alcohol de 70º, para impedir la formación de aerosoles y contaminación de superficies.
Disponer, bajo la vía de administración, un paño absorbente por su cara superior e impermeable por la inferior, con objeto de evitar que se contamine la ropa de cama o el sillón de administración, si se produce algún derrame.
Tanto en la administración SC como en la IM, en ningún momento se desconectará aguja de la jeringa, las conexiones deben ser luer-lock que impida la desconexión accidental, siendo desechadas como una sola pieza en el contenedor apropiado.
Finalizada la inyección, la extracción se realizará con una gasa impregnada en alcohol de 70º para evitar reflujos de medicación o goteo.
Durante la administración se utilizarán equipos de protección individual (ver apartado EPI). La protección ocular y respiratoria solo será necesaria si existe riesgo razonable de salpicadura o si por las condiciones del paciente se pudiera prever una desconexión accidental.
Administración intravenosa
Se recomienda la aplicación de sistemas cerrados de transferencia. Esta labor se tiene que llevar a cabo en la preparación, para que no sea necesario realizar ninguna conexión o desconexión durante la administración.
El sistema se eliminará como si fuera una sola pieza en el contenedor de específico, no se deben desconectar los fármacos utilizados.
El personal implicado en la técnica, debe ser formado para asegurar la utilización adecuada de los sistemas cerrados para lograr un óptimo funcionamiento, y reducir al mínimo el riesgo de goteos, derrames o creación de aerosoles.
Durante la administración se utilizarán equipos de protección individual (ver apartado EPI). La protección ocular y respiratoria solo será necesaria si existe riesgo razonable de salpicadura o si por las condiciones del paciente se pudiera prever una desconexión accidental.
Actuación ante derrames y exposiciones accidentales
Derrame
El trabajador se protegerá con bata impermeable, gafas o pantalla con protección lateral, calzas y 2 pares de guantes, uno de goma grueso y otro de látex sin polvo. En el caso de que el derrame se haya producido en el exterior de la CSB, se utilizará además mascarilla de protección respiratorio tipo FFP3. El orden de colocación será: calzas, bata, mascarilla, 1er par de guantes sobre la bata, 2º par de guantes y gafas ó pantalla.
Se empapará el derrame con celulosa o un paño absorbente (seco si se trata de líquidos y húmedo si es un polvo seco) antes de proceder a su limpieza. Si existen restos de cristales nunca se recogerán con la mano sino con la ayuda de unas pinzas (o cepillo recogedor), y se meterán en un contenedor pequeño rígido para objetos punzantes/cortantes.
La superficie seca debe limpiarse después con celulosa empapada de alcohol 70%. Se lavará la zona 3 veces con agua y jabón o limpiador detergente-lejía aclarando finalmente con abundante agua, siempre de las zonas menos contaminadas a las más contaminadas.
Retirarse los equipos de protección por este orden: 1er par de guantes, calzas, 2º par de guantes, mascarilla, bata y gafas. Desechar todo salvo si se utilizan gafas y las pinzas que podrán ser reutilizadas después de lavarlas cuidadosamente con agua y jabón (protegerse las manos con un par de guantes limpios para realizar esta operación).
Todos los residuos generados, así como el material empleado se tratarán como material contaminado a la hora de la eliminación.
Exposición accidental
Si el medicamento contacta directamente con la piel: se lavará inmediatamente la zona afectada con agua y jabón, durante unos 10 minutos. Si la piel se encontraba irritada, deberá ser examinada por un especialista.
Si el medicamento salpica los ojos: enjuagar el ojo afectado con agua o solución isotónica durante al menos 15 minutos y luego acudir al especialista.
En caso de ingestión accidental, es necesario acudir inmediatamente al médico.
En cualquiera de los casos, se comunicará al área de Salud Laboral del Servicio de Prevención para la realización de la vigilancia médica específica.
7. Tratamiento de residuos
Los residuos de los medicamentos se tratarán en los contenedores del Grupo III o Grupo IV, según el procedimiento de residuos vigente.
8. Actuación del servicio de prevención
La exposición potencial a MP en cada una de las actividades descritas dependerá del conjunto de medidas preventivas que se adopten, por lo que la posible exposición y su grado deberán establecerse en base a la evaluación de riesgos que se realice en cada caso concreto.
La magnitud del riesgo dependerá de:
La toxicidad inherente de cada medicamento.
El nivel de exposición, que se relaciona con:
La carga de trabajo.
Las condiciones de manipulación.
Protección ambiental.
Material de protección.
Técnica de manipulación. Implica procedimientos, adiestramiento y evaluación periódica.
El tiempo de exposición.
La fase del proceso. Hay mayor riesgo en la preparación y los derrames accidentales, aunque las medidas de protección deben incluir todas las fases del proceso.
Características del manipulador (edad reproductiva, exposición simultánea a otros agentes, etc.).
Otro aspecto importante a tener en cuenta es las posibles vías de penetración en el organismo de estas sustancias, que son:
Inhalación de los aerosoles y micro gotas que se desprenden durante la preparación de las soluciones de medicamentos peligrosos durante su administración, por rotura de ampollas, al purgar el sistema, etc.
Por contacto directo, por penetración del medicamento a través de la piel o de las mucosas.
Por vía oral: ingestión de alimentos, bebidas, cigarrillos contaminados.
Por vía parenteral: por introducción directa del medicamento a través de pinchazos accidentales o cortes producidos por rotura de ampollas.
9. Equipos de protección individual
El trabajador expuesto deberá estar cualificado, con conocimiento de los riesgos que corre si se expone sin la protección adecuada a estos medicamentos, así como de las condiciones que se exigen para la seguridad del paciente.
En apartados anteriores de este protocolo se han establecido las necesidades en cuanto a la utilización de Equipos de Protección Individual en función de cada medicamento (Apéndice 2 y Apéndice 3).
Las especificaciones que deben tener los EPIs en cada actividad no es el objeto de este documento.
10. Información y Formación e a los trabajadores
Con carácter general y de conformidad con los artículos 18 y 19 de la Ley de Prevención de Riesgos Laborales13, los trabajadores deben recibir una información y formación adecuadas sobre los riesgos derivados de la presencia de cualquier agente químico peligroso en el lugar de trabajo, así como sobre las medidas de prevención y protección que hayan de adoptarse. En particular, la formación del personal que trabaja con medicamentos biopeligrosos es un aspecto clave para evitar los riesgos laborales.
* La preparación de formas orales líquidas se refiere a la redosificación (cargar la jeringa), no a la elaboración del medicamento. ** Siempre que sea posible, en el reenvasado, se mantendrá el blíster original. *** Utilizar preferentemente forma oral líquida. En caso de no disponer de forma oral líquida, el fraccionamiento se realizará en Servicio de Farmacia en CSB II B2. FM: Fórmula magistral; SPRL: Servicio de Prevención de Riesgos Laborales; CSB II B2: Cabina de Seguridad Biológica Tipo II Clase B2. “Dado que la visualización de éste artículo no es en color, se han hecho constar las palabras: verde, amarillo, azul y rojo en las tablas debajo de cada medicamento. Este color indica la categoría de protección de ese medicamento según el código de colores de menor a mayor grado de protección durante la preparación y administración (verde, amarillo, azul y rojo) tal y como se explica en el procedimiento descrito”.
A continuación, se muestran resumidos los Medicamentos Peligrosos (MP) incluidos en guía farmacoterapéutica (GFT) del HIL.
El número entre paréntesis corresponde al número de lista de NIOSH en el que ese medicamento se encuentra incluido. Acenocumarol por similitud con warfarina (no incluido en NIOSH). Lista 1: medicamentos antineoplásicos o citostáticos. Lista 2: medicamentos no antineoplásicos que cumplen con uno o más criterios NIOSH para ser considerados de riesgo. Lista 3: medicamentos no antineoplásicos que tienen efectos sobre la reproducción. y que pueden afectar a hombres y mujeres que están intentando concebir de forma activa, y mujeres embarazadas o en periodo de lactancia, pero que no comportan riesgo para el resto del personal. 1 Siempre que sea posible, en el reenvasado, se mantendrá el blíster original. 2 Personal en riesgo reproductivo: hombres y mujeres que están intentando concebir de forma activa, y mujeres embarazadas o en periodo de lactancia. 3 En los tratamientos instaurados de forma continuada que requieran preparación, serán preparados en el Servicio de Farmacia(SF) en CSBIIB2. Los tratamientos excepcionales se prepararán según medidas de protección mencionadas, y en caso de continuidad, igualmente se asumirá la preparación en el SF. FM: Fórmula magistral; CSB II B2: Cabina de seguridad biológica Clase II Tipo B2; SCTM: sistema cerrado de transferencia de medicamentos. “Dado que la visualización de éste artículo no es en color, se han hecho constar las palabras: verde, amarillo, azul y rojo en las tablas debajo de cada medicamento. Este color indica la categoría de protección de ese medicamento según el código de colores de menor a mayor grado de protección durante la preparación y administración (verde, amarillo, azul y rojo) tal y como se explica en el procedimiento descrito”.
Autor para correspondencia. Correo electrónico: mgaspar@hilevante.com (Marisa Gaspar Carreño).
Level of risk posed by HDs.
Color code based on the specific management recommendations during the preparation and administration of the MP
The number between brackets corresponds to the number of the NIOSH list in which this medication is included. Acenocoumarol by similarity with warfarin (not included in NIOSH). List 1: Antineoplastic or cytostatic agents. List 2: Non-antineoplastic medications that meet one or more NIOSH criteria to be considered of risk. List 3: Non-antineoplastic medications with effects on reproduction, and that can affect men and women who are trying actively to conceive, and pregnant or breastfeeding women, but that don’t represent a risk for the rest of the staff. 1 Whenever possible, the original blister will be kept at re-packaging. 2 Staff at reproductive risk: men and women who are actively trying to conceive, and pregnant or breastfeeding women. 3 For treatments prescribed continuously and that need to be prepared, this will be done at the Pharmacy Unit (PU) in CSBIIB2. Exceptional treatmetns will be prepared according to the protection measures already mentioned and, in case of persistence, their preparation will be similarly assumed by the PU. MG: Magistral Formula; Class II B2 BSC: Class II Type B2 Biological Safety Cabinet; CLDT: Closed System for Drug Transfer.
Minimum characteristics of SPMs19
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.
Recommendations about the equipment to be used according to specific tasks in handling non-sterile hazardous drugs
(*) It is considered that there is Risk of Splashing in the following situations: there is risk of resistance by the patient, administration diluted in liquid, and administration through feeding tube.
Recommendations about the equipment to be used according to specific tasks in handling sterile hazardous drugs
(*) It is considered that there is Risk of Splashing in the following situations: there is risk of resistance by the patient, administration diluted in liquid, and administration through feeding tube.
Individual Protection Equipment. Recommended SPMs for different handling of hazardous drugs
Adapted from Source “Guía de Buenas Prácticas para Trabajadores Profesionalmente Expuestos a Agentes Citostáticos” (“Good Practice Guidelines for Workers Professionally Exposed to Cytostatic Agents”) (Escuela Nacional de Medicina del Trabajo. Instituto de Salud Carlos III. Ministerio de Economía y Competitividad. Asociación Madrileña de Medicina del Trabajo en el Ámbito Sanitario (AMMTAS) 2014). Source: “Monografías de Farmacia Hospitalaria y Atención Primaria. Medicamentos Peligrosos.” Issue 6. Year 2016.
* Preparation of liquid oral formulations refers to re-dosing (charging the syringe), not to the production of the medication. ** Whenever possible, the original blister will be kept at re-packaging. *** Use preferably the liquid oral formulation. If no liquid oral formulation is available, splitting will be done at the Pharmacy Unit in a Class II B2 BSC. MF: Magistral Formula; ORPU: Occupational Risk Prevention Unit; Class II B2 BSC: Class II Type B2 Biological Safety Cabinet. Since the display of this article is not in color, the words green, yellow, blue and red have been recorded in the tables below each medication. This color indicates the category of protection of that drug according to the color code from the lowest to the highest degree of protection during the preparation and administration (green, yellow, blue and red) as explained in the procedure described“.
The number between brackets corresponds to the number of the NIOSH list in which this medication is included. Acenocoumarol by similarity with warfarin (not included in NIOSH) List 1: Antineoplastic or cytostatic agents. List 2: Non-antineoplastic medications that meet one or more NIOSH criteria to be considered of risk. List 3: Non-antineoplastic medications with effects on reproduction, and that can affect men and women who are trying actively to conceive, and pregnant or breastfeeding women, but that don’t represent a risk for the rest of the staff. 1 Whenever possible, the original blister will be kept at re-packaging 2 Staff at reproductive risk: men and women who are actively trying to conceive, and pregnant or breastfeeding women. 3 For treatments prescribed continuously and that need to be prepared, this will be done at the Pharmacy Unit (PU) in CSBIIB2. Exceptional treatmetns will be prepared according to the protection measures already mentioned and, in case of persistence, their preparation will be similarly assumed by the PU. MG: Magistral Formula; Class II B2 BSC: Class II Type B2 Biological Safety Cabinet; CLDT: Closed System for Drug Transfer. Since the display of this article is not in color, the words green, yellow, blue and red have been recorded in the tables below each medication. This color indicates the category of protection of that drug according to the color code from the lowest to the highest degree of protection during the preparation and administration (green, yellow, blue and red) as explained in the procedure described“
Recomendaciones de equipo a utilizar según tareas específicas en la manipulación de medicamentos peligrosos no estériles
(*) Se considera que existe riesgo de salpicadura en las siguientes situaciones: existe riesgo de resistencia por parte de paciente, administración desleída en líquido y administración por sonda de alimentación.
Recomendaciones del equipo a utilizar según tareas específicas en la manipulación de medicamentos peligrosos estériles
(*) Se considera que existe riesgo de salpicadura en las siguientes situaciones: existe riesgo de resistencia por parte de paciente, administración desleída en líquido y administración por sonda de alimentación.
Equipos de protección individual - EPI recomendados para las diferentes manipulaciones de Medicamentos Peligrosos.
Adaptación de Fuente Guía de Buenas Prácticas para Trabajadores Profesionalmente Expuestos a Agentes Citostáticos (Escuela Nacional de Medicina del Trabajo. Instituto de Salud Carlos III. Ministerio de Economía y Competitividad. Asociación Madrileña de Medicina del Trabajo en el Ámbito Sanitario (AMMTAS) 2014) Fuente: Monografías de Farmacia Hospitalaria y Atención Primaria. Medicamentos Peligrosos. Número 6. Año 2016.
* La preparación de formas orales líquidas se refiere a la redosificación (cargar la jeringa), no a la elaboración del medicamento. ** Siempre que sea posible, en el reenvasado, se mantendrá el blíster original. *** Utilizar preferentemente forma oral líquida. En caso de no disponer de forma oral líquida, el fraccionamiento se realizará en Servicio de Farmacia en CSB II B2. FM: Fórmula magistral; SPRL: Servicio de Prevención de Riesgos Laborales; CSB II B2: Cabina de Seguridad Biológica Tipo II Clase B2. “Dado que la visualización de éste artículo no es en color, se han hecho constar las palabras: verde, amarillo, azul y rojo en las tablas debajo de cada medicamento. Este color indica la categoría de protección de ese medicamento según el código de colores de menor a mayor grado de protección durante la preparación y administración (verde, amarillo, azul y rojo) tal y como se explica en el procedimiento descrito”.
El número entre paréntesis corresponde al número de lista de NIOSH en el que ese medicamento se encuentra incluido. Acenocumarol por similitud con warfarina (no incluido en NIOSH). Lista 1: medicamentos antineoplásicos o citostáticos. Lista 2: medicamentos no antineoplásicos que cumplen con uno o más criterios NIOSH para ser considerados de riesgo. Lista 3: medicamentos no antineoplásicos que tienen efectos sobre la reproducción. y que pueden afectar a hombres y mujeres que están intentando concebir de forma activa, y mujeres embarazadas o en periodo de lactancia, pero que no comportan riesgo para el resto del personal. 1 Siempre que sea posible, en el reenvasado, se mantendrá el blíster original. 2 Personal en riesgo reproductivo: hombres y mujeres que están intentando concebir de forma activa, y mujeres embarazadas o en periodo de lactancia. 3 En los tratamientos instaurados de forma continuada que requieran preparación, serán preparados en el Servicio de Farmacia(SF) en CSBIIB2. Los tratamientos excepcionales se prepararán según medidas de protección mencionadas, y en caso de continuidad, igualmente se asumirá la preparación en el SF. FM: Fórmula magistral; CSB II B2: Cabina de seguridad biológica Clase II Tipo B2; SCTM: sistema cerrado de transferencia de medicamentos. “Dado que la visualización de éste artículo no es en color, se han hecho constar las palabras: verde, amarillo, azul y rojo en las tablas debajo de cada medicamento. Este color indica la categoría de protección de ese medicamento según el código de colores de menor a mayor grado de protección durante la preparación y administración (verde, amarillo, azul y rojo) tal y como se explica en el procedimiento descrito”.
