How should information be presented on a medication label for cancer therapy to minimise errors?

From Cancer Guidelines Wiki

Introduction

Clear and legible labelling of all medications is an essential component of medication safety. Labels should enable easy identification of the medication, route, dose and patient for administration by a healthcare professional, carer or for self-administration by the patient.


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Evidence Summary

Labelling of injectable medicines and the devices used to deliver them has been identified as a patient safety issue.[1]

Poorly designed label templates, insufficient detail, the use of confusable medicine names and the use of non standard or abbreviated language on labels all contribute to the overall risk of medicine selection errors by health professionals and patients.[2][3][4][5][6] The risks are applicable to all cancer medications and supportive therapy intended to be delivered by any route.

Inadvertent administration by the wrong route can result in serious or fatal consequences. Labelling that distinguishes those medications intended for intravenous administration from those intended for administration by other routes reduces administration error.[7][8][9]

Using barcode technology on medication labels is effective in minimising errors and assists in verifying the selection of the correct product for a patient where the product and label are scanned during the final dispensing process.[10]

The Pharmacy Board of Australia and The Australian Commission on Safety and Quality in Health Care provide standards and guidance on labelling of all medicinal products including user applied labelling of injectable medicines, fluids and lines.[10][1][11]


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Recommendations

The following recommendations are made in addition to the Pharmacy Board of Australia "Guidelines for dispensing of medicines" (Section 6: Labelling of dispensed medicines)[10] and State and Commonwealth legislation and requirements for the labelling of medicines.

Table12 provides the requirements for labelling of cancer and supportive care medications.


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A documented procedure for the labelling of all medications for administration by all routes in the inpatient and outpatient setting should be available.


A uniform labelling template that presents information in a consistent manner should be adopted to ensure easy identification of the medication, route, dose and patient (Neuss, 2017; Goldspiel, 2015; Carrington, 2010).


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Labels should be applied immediately after preparation of a medication.


Labels should not obscure the product name, batch number, expiry date or scannable barcode of the original packaging or diluent container.


Rate and duration of administration on parenteral products should be specified to assist nursing staff in selecting the correct rate.


Medication labels should be mechanically printed in permanent ink (not handwritten).


The minimum font size for patient name, medication name and dose should be 12 point or equivalent as larger font sizes result in fewer reading errors (Trudeau, 2009; Institute for Safe Medication Practices, 2010).


Refrigeration can reduce the adhesiveness of labels causing them to become detached from the product. Adhesive strength of the labels should be such that the labels do not detach from the medication. Removable labels should not be used.


The labelling of nurse prepared medications must comply with the National Standard for User Applied Labelling (Australian Commission on Safety and Quality in Health Care, 2015).

(Neuss, 2017)[12] ;(Goldspiel, 2015)[13] ;(Carrington, 2010)[4][5] ;(Trudeau, 2009)[2] ;(Institute for Safe Medication Practices, 2010)[3] ;(Australian Commission on Safety and Quality in Health Care, 2015)[11]


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Tables

Table 12: Details to be included on labels for cancer medication [10][14][3][2][13][12][15]

Patient’s first name and surname
  • For inpatient administration two unique patient identifiers must also be present (e.g. date of birth and institution identifier).
Medication name in full
  • Abbreviations and chemical names must not be used.
  • The name must be in the generic form and consistent with Australian Medicines Terminology (Australian Government, Australia Digital Health Agency).[16] Australian nomenclature must be used where it may differ from the US and Europe (e.g. mitozantrone v mitoxantrone).
  • If a brand, propriety or trade name is required for safety reasons, this should not form the main part of the medication name (e.g. Kadcyla® may be included on the label to distinguish trastuzumab emtansine from trastuzumab).
  • Clinical trial names must only be used in the context of approved clinical trials.
  • If a product contains two or more active ingredients they should all appear in the same field.
  • Tall Man lettering for medicines on the National Tall Man Lettering List should be considered (Australian Commission on Safety and Quality in Health Care, 2011).[17]
Medication strength in the appropriate and recognised dose unit
  • The use of decimal points should be avoided where possible (e.g. 1250 mg is preferable to 1.25 grams) (Australian Commission on Safety and Quality in Health Care, 2011).[18]
Ancillary and cautionary labels
  • Cytotoxic warning labels must be placed on all cytotoxics in accordance with local Health and Safety requirements. Suggested label is a permanent, adhesive purple cytotoxic warning label with the distinctive warning: “Cytotoxic, Handle with Care”.
  • Other cautionary and advisory labels should be added to the container as required.
  • Storage conditions should be included where applicable (e.g. refrigerator requirements for oral and injectable products).
ADDITIONAL RECOMMENDATIONS FOR PARENTERAL AND ASEPTICALLY PREPARED CANCER MEDICATIONS
The strength or total quantity of agent/medicine, the approximate total volume
  • The total dose should be expressed as a total concentration (e.g. 25 mg in 52 mL).
  • The diluent must be included (e.g. Sodium Chloride 09%) where appropriate for infusional products.
Route of administration
  • The route of administration should be specified in full where label space permits.
  • The administration route should be clearly highlighted where:
    • The injection/infusion is given by different routes (e.g. bortezomib, azacitidine, trastuzumab and rituximab may be given intravenously and subcutaneously).
    • The medication is intended for administration by the intraperitoneal route and is presented in an intravenous infusion bag.
  • Distinctive warning labels are to be placed on vinca alkaloids: “FOR INTRAVENOUS USE ONLY. FATAL IF ADMINISTERED BY ANY OTHER ROUTE”.
Preparation date and expiry date

The time of expiry should be included where applicable. It is common to include the time of expiry where the stability is less than 24 hours from preparation.

ADDITIONAL RECOMMENDATIONS FOR NON-PARENTERAL CANCER MEDICATIONS
Dosing instructions where applicable for patients self-administering
  • Instructions should be clear and unambiguous.
  • 'As directed’ should never be used regardless of the doctor’s instruction or the patient’s knowledge of the dosing regimen.
  • The total dose required. If the patient is required to take two different strengths of tablets to make up the dose (e.g. capecitabine 150 mg and 500 mg), then the dose instructions must include the number of tablets to take of each strength and the total dose.
  • The intended period of treatment including start and stop dates for short term or intermittent treatment (e.g. if chemotherapy is to be taken on days one to four inclusively then the label must specify the actual calendar dates to start and stop).
  • Steps must be taken to highlight different strengths of the same tablets/capsules to aid patient understanding.
  • For supportive therapy such as antiemetics, growth factor support and pre medication steroids that need to be taken/administered on specified days (e.g. pegfilgrastim on day two) the date should be included on the label.
  • Cautionary information about when to take in relation to food ingestion and other medications.
  • Dose instructions on labels should be considered for oral cytotoxics administered in the inpatient setting by nursing staff to minimise errors in dosage on administration.
The total quantity supplied
  • The dispensing label is to be firmly attached to the immediate container or to each immediate container where there are multiple containers.[10]
  • Boxes must NEVER be taped together with a label on one box.
  • Where more than one container of the same medicine is given then the following Warning label (or similar) must be used: ‘This is x of y number of containers containing the same medicine. Please use the contents of one container before starting another’.


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References

  1. 1.0 1.1 Australian Commission on Safety and Quality in Health Care. Safety and Quality Improvement Guide, Standard 4: Medication Safety. Sydney: ACSQHC; 2012 Available from: http://www.safetyandquality.gov.au/wp-content/uploads/2012/10/Standard4_Oct_2012_WEB.pdf.
  2. 2.0 2.1 2.2 Trudeau M, Green E, Cosby R, Charbonneau F, Easty T, Ko Y, et al. Patient safety issues: key components of chemotherapy labelling. Toronto (ON): Cancer Care Ontario; 2009 [cited 2016 Sep] Available from: https://www.cancercare.on.ca/common/pages/UserFile.aspx?fileId=50191.
  3. 3.0 3.1 3.2 Institute for Safe Medication Practices (ISMP). Principles of designing a medication label for intravenous piggyback medication for patient specific, inpatient use. [homepage on the internet]; 2010 [cited 2017 Apr]. Available from: http://www.ismp.org/Tools/guidelines/labelFormats/Piggyback.asp.
  4. 4.0 4.1 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.
  5. 5.0 5.1 Carrington C, Weir J, DO C. Study to support the standardization of the prescribing, dispensing and labeling of etoposide formulations in Australia. Asia Pac J Clin Oncol 2010 Sep;6(3):173-86 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/20887498.
  6. Stefanou A, Siderov J, Society of Hospital Pharmacists of Australia Committee of Specialty Practice in Oncology.. Medical errors. Dosage nomenclature of bleomycin needs to be standardised to avoid errors. BMJ 2001 Jun 9;322(7299):1423-4 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/11417551.
  7. Australian Commission on Safety and Quality in Health Care. High Risk Medication Alert – Vincristine. [homepage on the internet]; 2005 Dec [cited 2016 Sep]. Available from: https://safetyandquality.gov.au/wp-content/uploads/2012/01/valert.pdf.
  8. Gilbar PJ, Seger AC. Fatalities resulting from accidental intrathecal administration of bortezomib: strategies for prevention. J Clin Oncol 2012 Sep 20;30(27):3427-8 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/22851559.
  9. Gilbar PJ, Carrington CV. Preventing intrathecal administration of vincristine. Med J Aust 2004 Oct 18;181(8):464 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/15487972.
  10. 10.0 10.1 10.2 10.3 10.4 Pharmacy Board of Australia. Guidelines for dispensing of medicines. [homepage on the internet]; 2015 Sep [cited 2016 Sep]. Available from: http://www.pharmacyboard.gov.au/Codes-Guidelines.aspx.
  11. 11.0 11.1 Australian Commission on Safety and Quality in Health Care. National Standard for User-Applied Labelling of Injectable Medicines, Fluids and Lines. [homepage on the internet]; 2015 [cited 2017 Apr]. Available from: https://www.safetyandquality.gov.au/publications/national-standard-for-user-applied-labelling/.
  12. 12.0 12.1 Neuss MN, Gilmore TR, Belderson KM, Billett AL, Conti-Kalchik T, Harvet BE, et al. 2016 Updated American Society of Clinical Oncology/Oncology Nursing Society Chemotherapy Administration Safety Standards, Including Standards for Pediatric Oncology. Oncol Nurs Forum 2017 Jan 6;44(1):31-43 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/28067033.
  13. 13.0 13.1 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.
  14. Australian Commission on Safety and Quality in Health Care. The National Safety and Quality Health Service (NSQHS) Standards. [homepage on the internet]; 2014 [cited 2016 Sep]. Available from: https://www.safetyandquality.gov.au/our-work/assessment-to-the-nsqhs-standards/.
  15. Society of Hospital Pharmacists of Australia. Committee of Specialty Practice in Cancer Services. Standards of Practice for the Provision of Pharmaceutical Care of Patients Receiving Oral Chemotherapy for the Treatment of Cancer. J Pharm Pract Res 2007;37,147-150.
  16. Australian Government. Australian Digital Health Agency. Australian Medicines Terminology. [homepage on the internet]; 2017 Nov 19 [cited 2017 Apr]. Available from: http://www.digitalhealth.gov.au/get-started-with-digital-health/what-is-digital-health/clinical-terminology/australian- medicines-terminology.
  17. Australian Commission on Safety and Quality in Health Care. National Standard for the Application of Tall Man Lettering: Project Report. Sydney: ACSQHC; 2011 Available from: https://www.safetyandquality.gov.au/wp-content/uploads/2013/03/National-Standard-for-the-Application-of-Tall-Man-Lettering-Project-Report-with-appendices-PDF-700KB.pdf.
  18. Australian Commission on Safety and Quality in Health Care. Recommendations for Terminology, Abbreviations and Symbols used in the Prescribing and Administration of Medicines.; 2011 [cited 2016 Sep] Available from: http://www.safetyandquality.gov.au/wp-content/uploads/2012/01/32060v2.pdf.

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