What is the procedure for the Pharmacist when clinically verifying cancer prescriptions?

From Cancer Guidelines Wiki

Introduction

Clinical verification of an order or prescription for cancer therapy by a pharmacist provides assurance that the prescribed treatment is accurate and appropriate for the patient and their specific cancer diagnosis. A step-wise, process-driven approach to clinical verification of cancer therapy is essential to minimise medication errors and optimise safety in the process of providing cancer therapy.[1][2][3][4]


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Evidence Summary

When verifying a prescription the pharmacist must ensure that the prescription is valid, the medicine is clinically appropriate for the patient and information is provided to the patient to ensure safe and appropriate use of the medicine.[5]

A pharmacist must take reasonable steps to ensure that the dispensing of a medicine is consistent with the medical needs of the person for whom the prescription or order is intended. All health service organisations in Australia have mechanisms in place for the safe dispensing and supply of medicines. The prevention of medication errors is supported by standardised and systematic processes within the medication management pathway.[6]

Evidence substantiates the need for clinical verification of all cancer medication orders prior to administration of these medications to patients. Over 1.5 million Australians are estimated to experience an adverse event from medicines every year which accounts for approximately 2-3% of all hospital admissions, with at least half of these admissions being avoidable.[6]

For systemic cancer therapies the risks associated with incorrect prescribing, dispensing and administration are well described in the literature,[7][8][9][10][4][11] and risk minimisation processes are essential to maximise patient safety. Clinical verification of cancer medication orders by pharmacists provides high levels of assurance that the prescribed treatment is accurate [1][12][3] and is consistent with guidelines issued by the Pharmacy Board of Australia.[5]


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Recommendations

Consensus-based recommendationQuestion mark transparent.png

All prescribed cancer therapy and associated supportive care medications (by any route of administration) must be clinically verified by a pharmacist prior to dispensing and administration to, or by, a patient. Verification must be performed according to the protocol and the patient’s treatment plan and individual parameters (Goldspiel et al, 2015; Carrington et al, 2010).

The five “P”s should be followed to successfully verify a cancer therapy medication order:

1. Patient details and dosing variables

2. Prescription/medication order

3. Protocol and scheduling

4. Prescribed medication, dose calculations and administration

5. Patient organ function and laboratory blood tests

Table 11 provides recommendations on details that must be verified by the pharmacist.


The pharmacy verification process must be documented in an up-to-date local procedure which outlines the individual systematic checks that pharmacists are required to undertake when verifying cancer medication orders prior to dispensing, supply and administration.


Any identified discrepancies, anomalies or errors must be clarified and resolved with the prescriber. All significant interventions should be documented in the patients’ healthcare record.


The pharmacist responsible for the verification must sign and date each cancer medication order to confirm verification has been completed. Where electronic medication management systems are in use the pharmacist must ensure that electronic verification is performed securely and in line with local procedures and state legislation.


A patient medication history must be taken from the patient and documented on first cycle of chemotherapy or when the protocol is changed (Australian Pharmaceutical Advisory Council, 2005; The Society of Hospital Pharmacists of Australia, 2013). The pharmacist must ensure regular review with the patient that captures any changes to the patients usual medications or commencement of new medications. The pharmacist must maintain an up-to-date treatment history relating to all chemotherapy medications, doses, variations and treatment dates (Carrington et al, 2010).


Practice pointQuestion mark transparent.png

Physical and staffing resources should enable the pharmacist to verify all cancer medication orders and prescriptions away from distractions and interruptions to maximise safety.


An independent check should be performed by a second pharmacist with appropriate training and demonstrated competence in verifying cancer therapy when possible and supported by staffing resources. This should include a check of any manual dosage calculations.


When a patient is admitted to hospital and is already receiving cancer chemotherapy or targeted therapy (oral or parenteral) the original prescriber or an appropriate clinician with experience in haematology/oncology must be contacted to verify whether cancer therapy is to continue or whether dose adjustments or withholding of therapy is necessary.


Certain populations may be at increased risk of toxicities from chemotherapy (e.g. patients with chromosomal abnormalities including Down Syndrome, Ataxia Telangiectasia and Fanconi Anaemia etc). These patients require careful consideration for dosing, particularly chemotherapy. Documented guidelines should be followed for chemotherapy dosing in obese patients where there is limited guidance available within the patient’s protocol.

(Goldspiel et al, 2015)[13] ;(Carrington et al, 2010)[3] ;(Australian Pharmaceutical Advisory Council, 2005)[14] ;(Society of Hospital Pharmacists of Australia, 2013)[15]


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Tables

Table 11: Cancer therapy order details to be verified by the pharmacist [1][16][17]

The following information must be verified:
1. Patient details, patient parameters and body surface area (BSA)

Check points:

  • The patient's first name and surname, gender, date of birth and institution identifier (e.g. unit/hospital number) is recorded on the medication chart.
  • Adverse medicine reactions/allergies are documented on the order, or if not reported 'nil known allergies’ is recorded.
  • Patient dosing variables as appropriate for the dosing calculation are recorded (height, weight, body surface area).
  • Frequency of monitoring and checking of patient’s height and weight are followed according to protocol and/or local guidelines. For paediatric patients, ensure height and weight used for any dose calculations are current for that cycle and/or day of treatment.
  • The BSA is correctly calculated according to the locally agreed BSA formula (e.g. Mosteller[18]; Dubois & Dubois[19])
  • A current patient treatment plan is documented and available.
  • A medication history is taken and documented by the pharmacist at the initial and subsequent cycles to include prescribed medication, over the counter and herbal medication and must take into account any changes in medication during treatment.
2. Prescription/medication order

Check points:

  • The medication order form complies with the institution’s current authorised format. These should be computer generated from an electronic prescribing system or a regimen specific pre-printed order template.
  • The cancer therapy regimen has been prescribed in line with current legal requirements and local prescribing guidelines and includes; prescriber's printed name, signature, date of prescribing and date of treatment. Treatment date may be different and should be clearly differentiated if the two differ.
  • The prescriber is locally authorised to prescribe the cancer therapy regimen.
  • The medication order is clear, legible and unambiguous and includes all other details as outlined in the prescribing section of these guidelines.
  • All cancer therapy medications to be administered by all routes have been prescribed as listed in the protocol.
  • If an electronic prescribing system is used to produce a paper chemotherapy prescription:
    • The printed order must be verified against the electronic copy to ensure there is no difference between the electronic and printed order.
    • The printed copy must be verified as the most current copy that matches the electronic order with respect to the date and time the treatment was ordered and printed.
3. Protocol and scheduling

Check points:

  • The protocol name and treatment arm (where relevant) is clearly documented on the order and the protocol has been validated and approved through local approval processes.
  • The patient’s prescribed treatment reflects the treatment documented in the current plan.
    • If it is the first cycle of the protocol confirm the regimen prescribed is the intended treatment and is appropriate according to the patient’s diagnosis, risk stratification, medical history, performance status and cancer therapy history.
    • Variations from the original protocol are intended by the prescriber, valid for the patient and protocol, and are documented with clinical justification.
  • The therapy and regimen have been prescribed according to the protocol definitions of cycle length and frequency. i.e. The length of course and time interval between each cycle is appropriate for the protocol and tumour type and the appropriate time period has passed between last cycle and current cycle.
  • The days of therapy are clearly stated for chemotherapy administered on multiple occasions (i.e. Days 1, 2, 3, 4, 5 NOT Days 1-5).
  • Chemotherapy duration and the timing for dispensing and administration are clear on the prescription. High risk ambiguous abbreviations have not been used (i.e. for ONE day of the week, NOT 1/7).
  • The dose per m2 or per kg is clearly documented for each individual dose, NOT just the cumulative dose for the cycle (i.e. 100mg/m2/dose for 5 days, NOT 500mg/m2/cycle).
4. Prescribed medication, dose calculations

Check points:

  • All cancer therapy and supportive care medications prescribed are appropriate for the regimen the patient is on and there are no unintended omissions.
    • All supportive pre medications, concurrent and post medications are appropriate for the protocol and the length of the course (e.g. antiemetics, mesna).
  • All doses and dose units are correct according to the protocol medication within the regimen.
    • Calculated doses utilise the intended dosing parameter in the protocol (e.g. per m2, per kg, flat dose or by area under the curve (AUC) for carboplatin).
    • All doses required to be calculated on a patient parameter have been calculated correctly according to patient weight, BSA and/or creatinine clearance.
    • Doses are appropriate according to any other relevant local guidelines (e.g. dose rounding, banding).
    • The prescribed dose for each individual medication is consistent with any dose modification of that medication in previous cycles or lines of treatment if appropriate (unless further modification is required or recommended by the protocol).
    • All cancer and supportive medication modifications are applied (e.g. dose reduction, dose escalation, medication substitutions) are correct and appropriate according to the protocol, patient parameters and/or previous experienced toxicities. Unless there is a documented reason for a dose escalation for a cancer medication that was previously dose reduced (e.g. allowed within a protocol, documented within the patient’s medical record or otherwise specified by the prescriber), this should always be queried with the prescriber.
  • Any medications omitted from the previous cycle due to adverse effects or contraindications and which are now prescribed, are confirmed as correctly reinstituted for the current cycle with the prescriber and/or patient medical records and/or protocol.
  • Any medications omitted from the current cycle compared to the previous cycle are confirmed as correctly omitted for the current cycle with the prescriber and/or patient medical records and/or protocol.
  • The administration route for each medication is correct according to the protocol and appropriate for the patient and medication prescribed and is clearly specified on the order.
    • For parenterally administered medications specify where appropriate the diluent type, diluent volume and bolus or infusion rates are correct and appropriate for the medication and regimen prescribed.
  • The sequencing of medications within any particular day of the regimen is correct according to the protocol (i.e. day 1, day 2 etc).
  • The regimen has been prescribed correctly in terms of consecutive and/or non-consecutive days stated in the protocol for multiple day cycles (e.g. Day 1, 2 and 3 or Days 1, 8, 15). The appropriate cancer and supportive care medications have been prescribed on the correct days according to the protocol.
  • The maximum ceiling dose for any single medication dose has not been exceeded if defined within the protocol (e.g. vincristine max dose 2mg).
  • Maximum lifetime cumulative doses for individual medications will not be exceeded for the cycle to be administered where relevant (e.g. anthracyclines).
  • All known previous adverse reactions and allergies are documented and the patient has no known or documented allergies/hypersensitivity reactions to any of the medications prescribed. This should be facilitated by medication history taking by a pharmacist at the initial and subsequent cycles.
    • Where a patient has a documented prior reaction to a medication that is prescribed then the appropriateness of administering the medication to the patient must be discussed and confirmed with the prescriber.
  • Potential medication-medication and medication-disease interactions are identified and discussed with the prescriber including appropriate action (e.g. ceasing medication, changing medication or changing dose). Referral back to the original specialist may be needed for some medications (e.g. cardiologist for blood pressure medications).
  • Infusion solutions are compatible with other medications ordered and are appropriate for the patient's access device. The volume of administration is appropriate for the size and fluid requirements of the patient. This is particularly important for paediatrics and patients with renal impairment.
5. Patient organ function and laboratory blood tests

Check points:

  • All relevant patient organ function parameters and full blood count results are available and have been taken from patients within the locally agreed/protocol specified timeframe prior to cancer therapy administration.
  • The absolute neutrophil count and platelet count is appropriate for administration of chemotherapy.
  • The renal and hepatic function based on recent blood results is appropriate for all cancer and supportive medication doses.
    • Contact the prescriber in the event of organ dysfunction to recommend dosage modifications according to available dosage modification guidelines and/or local protocol.
    • The method for calculation of renal function is locally approved for cancer therapy (e.g. eGFR).
  • All other organ function parameters and blood results including electrolytes, cardiac and respiratory function tests are within normal or protocol specified limits.
  • Other tests are performed as appropriate according to the medication, regimen and protocol.


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References

  1. 1.0 1.1 1.2 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).
  2. 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.
  3. 3.0 3.1 3.2 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.
  4. 4.0 4.1 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.
  5. 5.0 5.1 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.
  6. 6.0 6.1 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.
  7. Schwappach DL, Wernli M. Medication errors in chemotherapy: incidence, types and involvement of patients in prevention. A review of the literature. Eur J Cancer Care (Engl) 2010 May;19(3):285-92 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/19708929.
  8. 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.
  9. Markert A, Thierry V, Kleber M, Behrens M, Engelhardt M. Chemotherapy safety and severe adverse events in cancer patients: strategies to efficiently avoid chemotherapy errors in in- and outpatient treatment. Int J Cancer 2009 Feb 1;124(3):722-8 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/18989899.
  10. National Patient Safety Agency (NPSA). A themed review of patient safety incidents involving anti-cancer medicines. 1 November 2003 – 30 June 2008. [homepage on the internet] UK: NHS; 2010 Oct Available from: http://www.nrls.npsa.nhs.uk/resources/clinical-specialty/cancer-oncology/?entryid45=75475&p=2.
  11. Blum M, Peck V, Seltzer T, Goldberg-Berman J. Alert: 6-mercaptopurine may be erroneously dispensed instead of propylthiouracil. Thyroid 2005 Nov;15(11):1315 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/16356101.
  12. Jaadar Y, Vidts LA, Byl B, Jancys A, Adin DE, Vandorpe A, et al. The role of the pharmacist in improving the safety of chemotherapy and treatment with monoclonal antibodies. European Journal of Oncology Pharmacy 2014;8(3):13-8.
  13. 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 Pharmaceutical Advisory Council. Guiding principles to achieve continuity in medication management.; 2005 [cited 2016 Sep] Available from: http://www.health.gov.au/internet/main/publishing.nsf/Content/5B47B202BBFAFE02CA257BF0001C6AAC/$File/guiding.pdf.
  15. Society of Hospital Pharmacists of Australia. SHPA Standards of Practice for Clinical Pharmacy Services. Chapter 1: Medication reconciliation. J Pharm Pract Res 2013;43,S1-S7.
  16. Goldspiel BR, DeChristoforo R, Hoffman JM. Preventing chemotherapy errors: updating guidelines to meet new challenges. Am J Health Syst Pharm 2015 Apr 15;72(8):668-9 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/25825190.
  17. Carrington C, Stone L, Koczwara B, Searle C. Development of guidelines for the safe prescribing, dispensing and administration of cancer chemotherapy. Asia Pac J Clin Oncol 2010 Sep;6(3):213-9 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/20887504.
  18. Mosteller RD. Simplified calculation of body-surface area. N Engl J Med 1987 Oct 22;317(17):1098 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/3657876.
  19. Du Bois D and Du Bois E. A formula to estimate the approximate surface area if height and weight be known. Arch Intern Med 1916;17:863–71.

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