What is a hazardous drug?
A drug may be considered hazardous for occupational exposure due to characteristics such as carcinogenicity, genotoxicity, reproductive or developmental toxicity, and certain toxic effects at low doses. Identification uses scientific information, manufacturer documentation, and technical references. It is not limited to antineoplastic drugs nor is it based solely on the treatment name.
This fact sheet addresses the protection of workers from involuntary exposure. The therapeutic decision for the patient serves a different purpose and is the responsibility of the clinical team. A product useful in the treatment of a disease may require strict measures during its preparation or handling to protect those who work with it.
Identify the products in the center
The inventory must include the medication, active ingredient, presentation, and operations performed. The INSST’s INFOMEP database and the NIOSH lists are references for identification, along with updated manufacturer information. These lists have a defined scope and publication date; they should not be used as proof of safety for any product not listed on them.
The 2024 NIOSH list supersedes previous versions and reorganizes its tables. Therefore, copying old classifications without verifying their meaning can lead to errors. The center needs a procedure for evaluating additions and changes in presentation. It must be clear who reviews the information and how the instructions reach the units that handle the medication.
Evaluate the entire exposure circuit
The assessment includes receiving, storing, transporting, preparing, administering, cleaning, handling spills, and waste disposal. Presentation and handling influence the potential for exposure. Opening, breaking, crushing, or reconstituting the product can introduce situations different from handling an intact container; therefore, specific and clinically consistent instructions are required.
Skin exposure and surface contamination require special attention, in addition to inhalation, accidental ingestion, or contact with mucous membranes. Personnel involved after administration and during cleanup must be considered. The disposal of contaminated materials and, where applicable, excreta requires defined procedures based on risk.
Preventive framework and hierarchy of controls
In Spain, the framework for the prevention of chemical agents applies, and, where appropriate according to classification, the framework for carcinogenic, mutagenic, and reprotoxic agents. The consolidated text of Royal Decree 665/1997 should be consulted to determine its scope. Older technical references may describe useful controls and require updating of their regulatory sections.
The therapeutic approach cannot be altered haphazardly based on an isolated preventive decision. Pharmacy, prevention, and healthcare professionals must jointly assess presentations and processes that reduce handling and release. The goal is to integrate protection and clinical care, documenting the necessary measures when use cannot be avoided.
Containment and protective equipment
Preparation may require appropriate containment facilities and equipment, along with transfer systems compatible with the product and process. A sealed device does not automatically replace all other measures. Its scope, proper connection, personnel training, and the procedure in case of a loss of integrity must be verified.
Gloves, clothing, and eye and face protection are selected according to the task and anticipated exposure. Procedures for changing, removing, and disposing of these items must be clearly defined, taking care to avoid contaminating skin and surfaces. The choice should not be based solely on whether a particular piece of equipment is commonly used in healthcare settings; protection against chemical hazards requires appropriate performance.
Cleaning, incidents and health surveillance
Cleaning and decontamination procedures must specify responsible parties, products, sequence, and waste management, using criteria compatible with the drug and the facility. Routine cleaning and spill response should be clearly distinguished. Necessary materials and emergency contacts must be readily available at the location where an incident might occur.
In the event of accidental exposure, the protocol is activated, a health assessment is provided, and the incident is documented. The investigation must review the entire system. Health surveillance is tailored to individual risk and circumstances, including the protection of particularly vulnerable individuals, without disclosing clinical information to personnel who do not need to know it.
Practical example
A hospital introduces a new presentation of a medication identified as hazardous. Pharmacy and prevention review how it will be received, prepared, and administered, and discover a fractionation procedure not included in the unit’s instructions. An alternative presentation is studied, and the process is adjusted.
Before implementing the change, staff are trained, the availability of resources is verified, and the spill response is rehearsed. The subsequent review includes cleanup and waste management, in addition to the preparation. This approach prevents the protocol from ending at the pharmacy door and leaving other phases without specific instructions.
Check the effectiveness of the system
Monitoring can review system integrity, compliance with procedures, incidents, maintenance, and, when technically relevant, surface contamination. An analytical result requires methodology, context, and interpretation criteria; it should not be used as a universal certificate of absence of risk. The information should serve to correct the process.
Common errors include limiting the inventory to antineoplastic drugs, omitting cleaning staff, confusing chemical and biological risks, and maintaining outdated lists. Effective management links product, presentation, task, and controls, with shared responsibilities and a review process capable of keeping pace with the center’s therapeutic and organizational changes.
