The issue of medication safety is highly significant when cancer therapies (chemotherapy, monoclonal antibodies, targeted therapy and related medicines) are used as treatment modalities due to the high potential for harm from these medications and the disease context in which they are being used. The complexity of treatment regimens designed to achieve maximal anti-cancer effect balanced against acceptable toxicity leaves limited margin for error. Over-dosage can result in death due to adverse effects of the treatment while under-dosing can have significant implications for the management of the disease and patient outcomes.
Prescribing, dispensing and administration errors relating to cancer therapies that result in patient harm are well documented in the literature. Medication errors can occur for a number of reasons including procedural, technical and behavioural reasons. Errors can occur when human and system factors interact with the complex process of prescribing, dispensing and administration to produce an unintended and potentially harmful outcome.
The complex scheduling and nomenclature associated with cancer therapy regimens has resulted in use of abbreviations and acronyms that can easily be misinterpreted. Dosages are not always expressed consistently, leading to incorrect interpretation of protocols and doses used for treatments. The complexity of calculations associated with surface area based dosing or area under the curve algorithms can lead to inappropriate dosing when not fully understood by the staff applying them. Protocols may utilise a multitude of calculation methods for individual medications within that protocol (e.g. flat dosing for targeted therapies combined with body surface area dosing for chemotherapy) adding to a risk of miscalculation or interpretation. The utilisation of electronic management and prescribing systems has offered opportunities to enhance patient safety by minimising errors due to illegibility, use of abbreviations, terminology misinterpretation and miscalculation. However the use of electronic prescribing and information management systems do not completely eliminate errors and may introduce their own specific risks as an unintended consequence.
Developments and changes in medication delivery routes, location of services and the introduction of the newer immunotherapies with a new spectrum of side effects increase the need for ongoing education and competence related to the specialised knowledge base. Cancer treatments are not limited to specialised tertiary centres in metropolitan areas and may be delivered in smaller centres that provide services to rural and remote communities. The increasing use of oral agents for chemotherapy and targeted therapy puts additional responsibility on the patient to ensure appropriate self-administration. Education, provision of information and follow-up of the patient is essential in this setting to ensure understanding, compliance and appropriate dosing.
Intrinsically, medicine is evidence based from robust clinical trials and peer reviewed data. This is not always applicable in patient safety where one or a small number of unintended incidents or errors can support a local or wider change in practice, particularly where it is identified that the same incident could happen in other institutions (e.g. the inadvertent administration of vincristine via the intrathecal route).
Some areas of vulnerability may only be identified when an incident occurs that causes, or may cause harm, and is brought to the attention of providers and patients in a more public domain (e.g. the underdosing of chemotherapy due to documentation anomalies in protocol dosage, the incorrect dosing of etoposide and etoposide phosphate due to confusion surrounding two formulations, the off-protocol dosing of carboplatin in head and neck cancer).
What is not well documented are the potential errors and near misses that many professionals intercept and prevent on a day-to-day basis. These more subtle actions and associated outcomes occur by the application of local procedures and the expertise of the clinical team to minimise errors and maximise patient safety. The result of these interventions is ultimately linked to safety and quality of services and patient outcomes even if they are not well published. Many institutes will have local procedures for reporting incidents and near misses and for analysis of these incidences. Spontaneous or individual driven incident reporting is not a robust method to identify all areas of medication safety as this relies on individuals identifying that patient safety has, or may be, compromised and on individuals reporting the incident.
Patient safety should be considered an essential part of any service and any safety initiative should be proactive and structured with patient outcome as the key focus. It is imperative that staff are aware of how their own behaviour and processes may impact on safety and outcomes. It is evident however that success in reducing the occurrence and incidence of errors is based on the multidisciplinary approach of all the healthcare professionals involved in the delivery of cancer therapy. The approach should be one that targets multiple stages of the treatment process from a clinical, safety and procedural aspect and one that includes the team and the patient at the point of care.
These guidelines are a multidisciplinary collaboration to provide recommendations for clinical practice and define best practice by using up-to-date available evidence alongside the expert, consensus opinion of cancer care professionals for the safe delivery of cancer therapy. They aim to prevent medication errors and patient harm by standardising the complex process of providing medications for the treatment of cancer.
The guidelines should be seen as point of reference for practitioners providing medications for the treatment of cancer and can be used as a framework to aid best practice within the multidisciplinary team. They should serve as a unifying platform that ensures seamless integration of processes, facilitates understanding of shared responsibility while setting standards to provide safe and effective treatment for cancer patients.
Regular review of the guidelines is essential to incorporate changes in practice and to reflect new methods for delivery of care. These guidelines will be maintained on the Cancer Council wiki platform. This will enable the guidelines to be updated as new literature is published to ensure currency.
COSA would like to congratulate all involved in this extensive process and in particular thank the Working Group Members who contributed their knowledge, skill and time to the development of these guidelines.
Dr Christine Carrington
Chair, Cancer Therapy Medication Safety Guidelines Working Group
- Institute for Safe Medication Practices. ISMP Safety Alert. Vincristine therapy: Days “4-11” misunderstood as days 4 through 11. [homepage on the internet]; 2006 Jun 29 [cited 2016 Sep]. Available from: http://www.ismp.org/newsletters/acutecare/articles/20060629.asp.
- Institute for Safe Medication Practices. ISMP Safety Alert. Lowdown on lomustine: We’d hate CeeNU make this mistake. [homepage on the internet]; 2004 Jul 15 [cited 2016 Sep]. Available from: http://www.ismp.org/Newsletters/acutecare/articles/20040715.asp.
- Institute for Safe Medication Practices. ISMP Safety alert: Fluorouracil error ends tragically, but application of lessons learned will save lives. [homepage on the internet]; 2007 Sep 20 Available from: http://www.ismp.org/newsletters/acutecare/articles/20070920.asp.
- Roush W. Dana-Farber death sends a warning to research hospitals. Science 1995 Jul 21;269(5222):295-6 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/7618095.
- Fluorouracil: dosing errors with infusion pumps. Prescrire Int 2014 Oct;23(153):242 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/25969854.
- Cohen MR. Hazard warning-vincristine overdose. Hosp Pharm, 1994;29:53.
- Phillips J. FDA Safety Page: Fatal medication errors associated with Temodar. [homepage on the internet]; 2003 Apr 7 [cited 2016 Sep]. Available from: http://drugtopics.modernmedicine.com/drug-topics/content/fda-safety-page-fatal-medication-errors-associated-temodar.
- Mort D, Lansdown M, Smith N, Protopapa K, Mason M. For better, for worse? A review of the care of patients who died within 30 days of receiving systemic anti-cancer therapy. London: National Confidential Enquiry into Patient Outcome and Death; 2008 Available from: http://www.ncepod.org.uk/2008report3/Downloads/SACT_report.pdf.
- Zaragoza MR, Ritchey ML, Walter A. Neurourologic consequences of accidental intrathecal vincristine: a case report. Med Pediatr Oncol 1995 Jan;24(1):61-2 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/7968797.
- Dyer C. Doctors suspended after injecting wrong drug into spine. BMJ 2001 Feb 3;322(7281):257 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/11157519.
- Independent Review Panel for SA Health. Independent review into the incorrect dosing of cytarabine to ten patients with acute myeloid leukaemia at Royal Adelaide Hospital and Flinders Medical Centre.; 2015 [cited 2016 Sep] Available from: http://www.hcasa.asn.au/documents/211-full-report-independent-review-into-the-incorrect-dosing-of-cytarabine/file.
- Vowels M. Review of Etoposide Phosphate dosing in the Oncology Unit. [homepage on the internet] Women’s and Children’s Hospital (WCH) Children, Youth and Women’s Health Service, Adelaide, South Australia.; 2008 [cited 2016 Sep]. Available from: http://www.health.sa.gov.au/Default.aspx?tabid=52&mid=449&ctl=ViewDetails&ItemID=1820&PageIndex=0.
- NSW Health Department. Off-protocol prescribing of chemotherapy for head and neck cancers. Inquiry under section 122 of the Health Services Act 1997.; 2016 [cited 2016 Sep] Available from: http://www.health.nsw.gov.au/Hospitals/Documents/section-122-final-report.pdf.