What is best practice when dispensing oral cancer treatment (chemotherapy and targeted therapy)?

From Cancer Guidelines Wiki

Introduction

Oral cancer therapy carries the same risks in terms of potential for error and toxicities as cancer therapies administered by other routes.[1][2]

Oral cancer therapy encompasses cytotoxic chemotherapy, targeted therapies and includes agents such as anagrelide, hydroxyurea and all-trans-retinoic-acid (ATRA). An increasing number of oral therapies have become available for cancer treatment in recent years particularly with regards to molecular targeted therapy. Although targeted therapies do not damage normal cells in the way cytotoxic chemotherapy does, they are still associated with toxic adverse effects and subject to risk of errors in prescribing, supply and administration.


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Evidence Summary

Oral cancer medications should be subject to the same rigorous safety control and procedures as cancer medications administered by other routes.

Errors that occur with oral cancer therapies frequently mirror those that occur with parenteral cancer therapies such as calculation errors, scheduling errors or omission of supportive therapies.[3] The self-administration of oral cancer therapies also introduces additional risks such as misunderstanding of complex dosing regimens with consequential mis-dosing and non-adherence.[4][5][6][7][8][9][10][11]

Errors and subsequent harm have occurred where patients have misinterpreted dosage instructions and where greater then needed quantities have been dispensed which enables patients to continue dosing beyond that clinically indicated.[10][12][8]

The pharmacist has an important role in ensuring safe provision of therapy and provision of patient education to permit safe self-administration in the home.[13][14][2][15][8] The role of the pharmacist in ensuring the safe provision of oral cancer therapy includes (but is not limited to) the clinical verification of prescriptions, dispensing of cancer therapy medications including supportive therapy (e.g. antiemetics, anti-diarrhoeals) and the provision of information and education to patients.[13][14][2][15][16][17]

Note: Further information on oral cancer therapy is provided under the clinical verification and patient information sections of these guidelines.


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Recommendations

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Verification


Prescriptions for oral cancer medications must be clinically verified by a pharmacist with appropriate training and skills in cancer pharmacy prior to being dispensed (Society of Hospital Pharmacists of Australia Committee of Specialty Practice in Cancer Services, 2007; Carrington et al, 2010; Rudnitzki and McMahon, 2015; British Oncology Pharmacy Association, 2013).


Prescriptions for oral cancer therapies should be verified using the same procedures and safety standards as those used to verify cancer therapy administered via other routes. In addition, the following should be verified:

  • The orders for both oral and parenteral cancer agents must be clinically verified at the same time if oral cancer medications are prescribed in conjunction with cancer medications administered via other routes (e.g. the treatment protocol XELOX contains intravenous oxaliplatin and oral capecitabine).
  • The duration of treatment for the oral cancer medication is clear and correct according to the protocol, and there is no ambiguity with regards to continuous and intermittent dosing. Intermittent dosing should be clearly stated as the defined duration treatment is required within the cycle (e.g. Temozolomide on days 1 to 5 inclusive in a 28 day cycle or Capecitabine days 1 to 14 inclusive in a 21 day cycle).
  • Where therapy is being administered for a defined cycle duration, the start and stop dates are stated and appropriate according to the protocol.
  • The dose prescribed can be safely administered using the strengths and formulations of medications that are available.
  • All supportive therapy required has been prescribed and is appropriate for the duration including antiemetics, anti-diarrhoeals and anti-infectives. Growth factor support may still be required with some protocols containing oral cancer therapy.

Dispensing


For oral cancer therapies administered for a finite course or stated duration, the quantity supplied should only be the quantity of tablets/capsules the patient requires for that cycle of treatment (Society of Hospital Pharmacists of Australia Committee of Specialty Practice in Cancer Services, 2007; Carrington et al, 2010). This type of intermittent scheduling is common with the traditional cytotoxic oral agents such as capecitabine, cyclophosphamide, melphalan, methotrexate etc.

This quantity may be less than the allowed PBS prescribed quantity however the use of PBS quantities as whole patient packs may pose a risk to patients if they contain more tablets than are needed for the cycle. If the amount supplied overrides the prescribed PBS quantity, then this should be documented and endorsed on the prescription/order.


For non-cyclical continuous cancer therapy, usually molecular targeted therapy, the exact quantity of oral cancer agent(s) required for that cycle of therapy should be supplied or until the next review is due. It is usual practice to provide one month’s supply per dispensing and for the patient to be reviewed monthly (or more frequently) until they are established on the therapy (Institute for Safe Medication Practices, 2014; Phillips, 2003; NHS National Patient Safety Agency UK, 2008).


Oral cancer medications are often classified as cytotoxic or hazardous agents. Pharmacists should refer to state and national guidelines and legislation for guidance on the safe handling of cytotoxic and hazardous agents. Oral cancer therapies should be stored in designated areas in a dispensary and be clearly labelled. Where more than one strength is available (e.g. capecitabine 150mg & 500mg or temozolomide with strengths ranging from 5mg to 180mg capsules), steps should be in place to adequately separate stock to minimise the risk of stock being incorrectly picked from the shelf.


Patient education


Pharmacists have a professional responsibility to provide patients with adequate written and verbal education to use medications safely and effectively (Pharmacy Board of Australia, 2015). The Patient Information section of these guidelines includes the requirements for patient education and provision of information regarding cancer therapy including chemotherapy, targeted therapy and supportive therapies and additional education requirements for oral cancer therapies.

(Society of Hospital Pharmacists of Australia Committee of Specialty Practice in Cancer Services, 2007)[16] ;(Carrington et al, 2010)[2] ;(Rudnitzki and McMahon, 2015)[4] ;(British Oncology Pharmacy Association, 2013)[18] ;(Society of Hospital Pharmacists of Australia Committee of Specialty Practice in Cancer Services, 2007)[15] ;(Institute for Safe Medication Practices, 2014)[12] ;(Phillips, 2003)[10] ;(NHS National Patient Safety Agency UK, 2008)[8] ;(Pharmacy Board of Australia, 2015)[17]


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Staff dispensing oral cancer medicines in the community setting or community pharmacies must have appropriate skills and training to verify oral cancer therapy. They must have access to all relevant treatment information and patient parameters to ensure they can confirm that the prescribed treatments and dose are appropriate for the patient. Access to a cancer pharmacist at the hospital/institute where the therapy has been initiated is important to clarify treatment related questions. The eviQ Cancer Education Online module “Cancer Medicines - the role that community pharmacists play in supporting their customers” provides practical learning activities addressing issues encountered in the community pharmacy setting (Cancer Institute NSW, 2017).


Dispensing chemotherapy from repeat prescriptions should be discouraged as changes can often occur to prescriptions due to clinical reasons. Where this is unavoidable, repeat prescriptions for subsequent cycles of oral cancer medicines should be confirmed with the prescriber before dispensing to ensure there has been no change to dose or treatment since the initial prescription was written. A chemotherapy order should also accompany the script. Where a change has been made, a new prescription should be requested and the old prescription/repeats destroyed (Society of Hospital Pharmacists of Australia Committee of Specialty Practice in Cancer Services, 2007).


Further discussions with clinicians and patients may be needed if a patient returns unused quantities of oral cancer medication with no clinical rationale or a patient runs out of supply before expected according to the dose prescribed. This may indicate over compliance, mis-dosing or non-adherence (Taylor et al, 2006; Spoelstra and Given, 2011; Spoelstra et al, 2013).


Child-proof caps must be used when dispensing non-blister packs or containers of oral chemotherapy (Society of Hospital Pharmacists of Australia Committee of Specialty Practice in Cancer Services, 2007).


Barcode scanning of product and computer generated labels should be used when dispensing oral chemotherapy (Weingart et al, 2011; Pharmacy Board of Australia, 2015).


Oral cancer agents should not be made available as imprest or ward stock (Society of Hospital Pharmacists of Australia Committee of Specialty Practice in Cancer Services, 2007).

(Cancer Institute NSW, 2017)[19] ;(Society of Hospital Pharmacists of Australia Committee of Specialty Practice in Cancer Services, 2007)[15] ;(Taylor et al, 2006)[7] ;(Spoelstra and Given, 2011)[5] ;(Spoelstra et al, 2013)[6] ;(Society of Hospital Pharmacists of Australia Committee of Specialty Practice in Cancer Services, 2007)[16] ;(Weingart et al, 2011)[20] ;(Pharmacy Board of Australia, 2015)[17]


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References

  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.
  2. 2.0 2.1 2.2 2.3 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.
  3. Weingart SN, Toro J, Spencer J, Duncombe D, Gross A, Bartel S, et al. Medication errors involving oral chemotherapy. Cancer 2010 May 15;116(10):2455-64 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/20225328.
  4. 4.0 4.1 Rudnitzki T, McMahon D. Oral agents for cancer: safety challenges and recommendations. Clin J Oncol Nurs 2015 Jun;19(3 Suppl):41-6 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/26030392.
  5. 5.0 5.1 Spoelstra SL, Given CW. Assessment and measurement of adherence to oral antineoplastic agents. Semin Oncol Nurs 2011 May;27(2):116-32 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/21514481.
  6. 6.0 6.1 Spoelstra SL, Given BA, Given CW, Grant M, Sikorskii A, You M, et al. Issues related to overadherence to oral chemotherapy or targeted agents. Clin J Oncol Nurs 2013 Dec;17(6):604-9 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/24113679.
  7. 7.0 7.1 Taylor JA, Winter L, Geyer LJ, Hawkins DS. Oral outpatient chemotherapy medication errors in children with acute lymphoblastic leukemia. Cancer 2006 Sep 15;107(6):1400-6 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/16909415.
  8. 8.0 8.1 8.2 8.3 NHS National Patient Safety Agency UK. Rapid Response Report (NPSA/2008/RRR001). Risks of incorrect dosing of oral anti-cancer medicines. [homepage on the internet]; 2008 Jan 22 [cited 2016 Sep]. Available from: http://www.nrls.npsa.nhs.uk/resources/?entryid45=59880.
  9. Moore S. Nonadherence in patients with breast cancer receiving oral therapies. Clin J Oncol Nurs 2010 Feb;14(1):41-7 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/20118025.
  10. 10.0 10.1 10.2 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.
  11. Letarte N, Gabay MP, Bressler LR, Long KE, Stachnik JM, Villano JL. Analyzing temozolomide medication errors: potentially fatal. J Neurooncol 2014 Oct;120(1):111-5 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/25026995.
  12. 12.0 12.1 Institute for Safe Medication Practices. ISMP Safety Alert. With oral chemotherapy, we simply must do better! [homepage on the internet]; 2014 Jul 17 [cited 2016 Sep]. Available from: https://www.ismp.org/newsletters/acutecare/showarticle.aspx?id=84.
  13. 13.0 13.1 Carrington C. Safe use of oral cytotoxic medicines. Australian Prescriber 2013;36(1):9-12.
  14. 14.0 14.1 Carrington C. Oral targeted therapy for cancer. Aust Prescr 2015 Oct;38(5):171-6 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/26648656.
  15. 15.0 15.1 15.2 15.3 Society of Hospital Pharmacists of Australia. Committee of Specialty Practice. Standards of Practice for the Provision of Consumer Medicines Information by Pharmacists in Hospitals. J Pharm Pract Res 2007;37,56-58.
  16. 16.0 16.1 16.2 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.
  17. 17.0 17.1 17.2 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.
  18. British Oncology Pharmacy Association (BOPA). Standards for Pharmacy Verification of Prescriptions for Cancer Medicines. [homepage on the internet]; 2013 [cited 2016 Sep]. Available from: www.bopawebsite.org (Members only section).
  19. Cancer Institute NSW. eviQ Cancer Treatments Online. [homepage on the internet]; 2017 Nov 20 [cited 2016 Sep]. Available from: https://www.eviq.org.au.
  20. Weingart SN, Spencer J, Buia S, Duncombe D, Singh P, Gadkari M, et al. Medication safety of five oral chemotherapies: a proactive risk assessment. J Oncol Pract 2011 Jan;7(1):2-6 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/21532801.

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