Antineoplastic drugs (ANDs) used for chemotherapy can cause secondary cancers in treated patients and can pose carcinogenic risks to health-sector workers anywhere along these drugs’ life cycle in a facility, from production to patient administration. Several PAHO/WHO Collaborating Centers (CCs) have experience addressing these hazards in the health sector. The objectives of this report are four-fold: 1) Provide an overview of longstanding research and prevention efforts, led by PAHO/WHO and its Occupational Health CCs, aimed at reducing the burden of occupational cancer in the Americas; 2) Discuss how robust AND exposure assessment and educational/outreach work by PAHO CCs can form the basis of exposure mitigation efforts among health-sector workers; 3) Through the presentation of original AND exposure assessment data from a pharmaceutical compounding facility in Chile, highlight relatively inexpensive methods by which such data can be generated; and 4) Discuss how effective, periodic environmental surveillance in healthcare facilities results in the identification of AND contamination in the work environment and enables the implementation of low-cost, high-impact interventions to reduce the risk of occupational cancer in health-sector workers, including in limited-resource settings.
The risk of health-sector worker exposure to ANDs and other hazardous drugs is an important issue for inclusion within PAHO/WHO’s broader efforts at reducing the impact of occupational cancer in the Americas. This report demonstrates that a wide range of accessible AND-exposure mitigation strategies are feasible at both a facility and a national policy level across the hemisphere.
The Food and Drug Administration (FDA), as a matter of long-standing policy, does not inform the public of instances whereby applications for new drugs or new indications for existing drugs have been rejected by the agency or withdrawn from consideration, nor does it disclose the agency’s analyses of the data submitted with such applications. This lack of transparency is unjustified and prevents patients, researchers, and healthcare providers from gaining insight into why a drug’s application was not approved. The FDA’s policy is particularly troubling in cases where the agency has found a currently marketed drug to be ineffective or unsafe for a newly proposed indication. Disclosure of the FDA’s findings in such cases would promote public health by encouraging healthcare providers to avoid prescribing drugs for unapproved (off-label) uses that the agency has deemed to be potentially dangerous or ineffective. The FDA’s counterpart agencies in Europe and Canada have demonstrated the feasibility of disclosing information on rejected and withdrawn drug marketing applications. The FDA should follow suit and allow the American public to know when a drug is deemed unsafe or ineffective for a certain use.
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