Good manufacturing practices for the preparation of cancer therapy in healthcare establishments and the transport of medications are important aspects of medication safety. It is beyond the scope of these guidelines to address all recommendations related to the actual preparation of parenteral cancer therapy and the transportation of cancer medication. The Society of Hospital Pharmacists of Australia (SHPA) and the Pharmacy Board of Australia provide detailed guidance and standards.
The process of clinical validation of the order and the actual preparation of the chemotherapy and targeted therapy should be considered as two separate functions. The therapy must be delivered to ‘the right place at the right time for the right person’ to enable treatment to commence.
Note: Section 31 of these guidelines (Pharmacist, Dispensing intrathecal therapy) gives additional recommendations on special safety considerations when providing intrathecal cancer therapy.
The preparation process must ensure that the therapy is stable in the required container and diluent for the required length of time. Where preparation is carried out by a third party compounder the institution must be satisfied that the products are prepared in accordance with appropriate standards. Consideration should be given to whether the compounder holds a manufacturing licence from the Therapeutic Goods Administration (TGA) for the relevant compounding site.
A reconciliation check with the product and the medication order must be carried out by the pharmacist before administration to the patient. The pharmacist doing the reconciliation check should not be the pharmacist that has clinically verified the order. Sufficient staff resources should be allocated to ensure this is possible.
Where preparation is carried out by a third party or external compounder/manufacturer there must be a process in place to ensure the final prepared product is checked against the medication order by a pharmacist at the institute where the cancer therapy is to be administered. The process should include a check against the original medication order before the product is provided to nursing staff for administration to the patient.
All cytotoxic chemotherapy must be delivered and stored separately from other non-cytotoxic products in an area and container dedicated to the purpose. The storage location and container must be labelled as such. Monoclonal antibodies and oral targeted therapies should be stored and delivered separately to cytotoxic chemotherapy where practical. A local risk assessment should be in place to support the preparation and delivery of monoclonal antibodies (Alexander et al, 2014).
Intrathecal chemotherapy has special requirements for preparation, transportation and delivery.
Appropriate information on stability and safety must be obtained before preparation where requests are made for products to be prepared outside of standard formulations or for administration via non-standard routes.
(Alexander et al, 2014)
- Goldspiel B, Hoffman JM, Griffith NL, Goodin S, DeChristoforo R, Montello CM, et al. ASHP guidelines on preventing medication errors with chemotherapy and biotherapy. Am J Health Syst Pharm 2015 Apr 15;72(8):e6-e35 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/25825193.
- Society of Hospital Pharmacists of Australia Manufacturing Working Party. SHPA Guidelines for Medicines Prepared in Australian Hospital Pharmacy Departments. Journal of Pharmacy Practice and Research 2010;40,133-143.
- Society of Hospital Pharmacists of Australia. Committee of Specialty Practice in Cancer Services. Standards of Practice for the Transportation of Cytotoxic Drugs from Pharmacy Departments. J Pharm Pract Res 2007;37,234-5.
- Pharmacy Board of Australia. Guidelines on compounding of medicines. [homepage on the internet]; 2015 Mar [cited 2016 Sep]. Available from: http://www.pharmacyboard.gov.au/Codes-Guidelines.aspx.
- International Society of Oncology Pharmacy Practicioners Standards Committee.. ISOPP standards of practice. Safe handling of cytotoxics. J Oncol Pharm Pract 2007;13 Suppl:1-81 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/17933809.
- Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme. Guide to Good Manufacturing Practice for medicinal products. Geneva: PIC/S; 2009 [cited 2016 Sep] Available from: https://www.tga.gov.au/sites/default/files/manuf-pics-gmp-medicines-annexes.pdf.
- Carrington C, Stone L, Koczwara B, Searle C, Siderov J, Stevenson B, et al. The Clinical Oncological Society of Australia (COSA) guidelines for the safe prescribing, dispensing and administration of cancer chemotherapy. Asia Pac J Clin Oncol 2010 Sep;6(3):220-37 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/20887505.
- Alexander M, King J, Bajel A, Doecke C, Fox P, Lingaratnam S, et al. Australian consensus guidelines for the safe handling of monoclonal antibodies for cancer treatment by healthcare personnel. Intern Med J 2014 Oct;44(10):1018-26 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/25302720.