Table 1.
Recommendations for Manufacturers and Distributors
Consideration |
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Packaging and segregation |
Effective packaging and segregation techniques should be used to avoid contamination prior to distribution. |
Packaging should clearly state whether segregation techniques have been used so that individuals unpacking the medications can take additional precautions if necessary. |
Packaging material should be durable, able to contain any accidental leakage during handling and transport, and tamper-proof. |
Package label should indicate that the agent is cytotoxic (eg, size-appropriate modifications of the European Society of Oncology Pharmacy yellow hand, the Association paritaire pour la santé et la sécurité du travail du secteur sociale's “C” symbol”). |
Distributors should ensure that the labeling on the packaging is intact and that oral cytotoxic agents are stored and transported separately from noncytotoxic agents. |
Minimizing handling of oral chemotherapeutic agents |
Manufacturers should provide the appropriate number of tablets or capsules per packing based on the amount needed for one cycle of therapy. If this approach is not an option, manufacturers should attempt to use unit packaging (ie, individual packaging for tablets or capsules). Additionally, based on treatment protocols for various diseases being treated and new data, manufacturers should consider preparing additional dosage strengths as appropriate. |
Because many patients inherently, or as a result of their disease, have difficulty swallowing tablets or capsules, a liquid formulation, or information on how to compound a liquid formulation, should be provided by the manufacturer. |
Educational materials |
Manufacturers should provide educational material regarding safe handling to each stakeholder, including physicians, RNs, pharmacy personnel, patients, and caregivers. |
Manufacturers should update patient education materials as new information becomes available. |