Handling and Disposal of Hazardous Drugs: SFDA Experience

Abstract Introduction: Hazardous drugs (HDs), with different dosage forms, pose exposure risks to healthcare providers, patients, caregivers, and the environment. They require special handling procedures, protective equipment, and disposal methods to minimize exposure risks. HDs may include chemotherapies, antiviral drugs, hormones, and bioengineered drugs. The effects of occupational exposure to HDs require further investigation, as exposure extends beyond healthcare providers to caregivers and the environment. Objectives: In 2020, Saudi Food and Drug Authority launched a project titled “Handling and Disposal of Oral HDs.” The project aimed to reduce exposure risks to oral HDs through improved safety measures in local product information. Materials and Methods: We identified oral HDs registered in Saudi Arabia until December 2022, categorized by National Institute for Occupational Safety and Health (NIOSH), and reviewed summary of product characteristics (SPCs) and patient information leaflets (PILs) from SDI, European Medicines Agency, and the Food and Drug Administration (FDA). We evaluated safety measures provided in Section 4.2 and Section 6.6 of the SPCs, as well as Section 3 and Section 5 in the PILs. Results: A total of 83 oral medications out of 139 HDs were registered in Saudi Arabia. Of these, 75% were categorized under NIOSH Table 2, while 25% met the criteria for NIOSH Table 1. In this project, labeling updates were requested from pharmaceutical companies for 76 out of the 83 total products (92%) to add new safety measures related to handling and disposal. Conclusion: The study revealed deficiencies in product information regarding the safe handling of oral HDs and highlighted the need for enhanced regulations. Collaborative efforts are required to improve product labeling, establish safety guidelines, and reduce exposure risks for healthcare personnel, caregivers, and the environment.