Additional information to support. The National Patient Safety Agency s Rapid Response Report Risks of incorrect dosing of oral anti-cancer medicines

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Additional information to support The National Patient Safety Agency s Rapid Response Report Risks of incorrect dosing of oral anti-cancer medicines Reference: NPSA/2008/RRR001 - issued on 22 January

1 Additional information to support The National Patient Safety Agency s Rapid Response Report Risks of incorrect dosing of oral anti-cancer medicines Reference: NPSA/2008/RRR001 - issued on 22 January 2008 The National Patient Safety Agency (NPSA) is alerting all healthcare staff involved in the use of oral anti-cancer medicines of potentially fatal outcomes if incorrect doses of these medicines are used. More of these oral anti-cancer medicines are being used in hospitals and in the community. During nearly 18 million doses were used in hospitals and 6 million doses used in the community in England. Risks are increased if non-specialist practitioners prescribe, dispense or administer these oral medicines and bypass the normal safeguards used for anti-cancer medicines that are injected. The NPSA has received reports of three recent deaths and a further four hundred patient safety incidents concerning oral anti-cancer medicines between November 2003 July Half of these reports concern the wrong dosage, frequency, quantity or duration of oral anti-cancer medicines. It is also likely that there are substantial numbers of unreported incidents. See Tables 1 5. There have been published reports highlighting the unmanaged risks concerning the use of oral anti-cancer medicines 1-3 The number of orally active agents available, particularly the targeted therapies, is likely to increase substantially in the near future. The term oral anti-cancer medicines include those with direct antitumour activity, which currently includes: bexarotene, busulfan, capecitabine, chlorambucil, cyclophosphamide, estramustine, etoposide, fludarabine, hydroxycarbamide, idarubicin, lomustine, melphalan, mercaptopurine, methotrexate, mitotane, procarbazine, tegafur/uracil, temozolomide, tioguanine, treosulfan, vinorelbine. In addition targeted therapies such as the kinase inhibitors: dasatinib, erlotinib, imatinib, sorafenib, and sunitinib are also included. Our use of this term does not include hormonal or anti-hormonal therapy used to treat cancer. 1

2 Table 1. Patient safety incidents involving oral anticancer medicines by care setting - November 2003 July 2007 Care Setting Incidents % Acute / general hospital % Community nursing, medical and therapy service (incl. community hospital) 5 1% Community pharmacy 4 <1% General practice 1 <1% Mental health service 1 <1% Total % Table 2. Patient safety incidents involving oral anticancer medicines by clinical outcome - November 2003 July 2007 Degree of harm Incidents % Death 3 <1% Severe 1 <1% Moderate 7 2% Low 23 5% No Harm % Total % Table 3. Patient safety incidents involving oral anticancer medicines by stage of medication process - November 2003 July 2007 Medication Process Incidents % Dispensing and preparation % Prescribing % Administration 98 22% Other 8 2% Total % Table 4. Patient safety incidents involving oral anticancer medicines by type of medication error - November 2003 July 2007 Medication Error Category Incidents % Wrong dose, strength, frequency or quantity % Wrong drug / medicine 42 9% Omitted medicine 75 17% Other % Total % 2

3 Table 5. Annual Usage of oral anticancer medicines by individual medicine 1 st January st December 2006 Annual usage in hospitals in England 2006 (Dose units) Annual usage in primary care in England 2006 (Dose units) Anti-cancer agent Capecitabine 8,303,541 10,471 Mercaptopurine 926,262 1,037,619 Chlorambucil 893,997 42,321 Cyclophosphamide 886, ,327 Etoposide 125, Hydroxycarbamide 4,146,552 4,700,728 Oral anticancer agent (un-specified) N/A N/A Melphalan 159,327 1,799 Fludarabine 179, Lomustine 14, Imatinib 1,493,802 12,997 Temozolomide 177, Procarbazine 106, Tretinoin 135, Vinorelbine Idarubicin 6,082 0 Treosulfan 15,768 0 Busulphan 60,777 0 Tioguanine 16,497 3,785 Mesna 27,378 0 Total 17,687,122 6,099,989 3

4 Table 6. Patient safety incidents involving oral anticancer medicines by individual medicine - November 2003 July 2007 Reported Incidents November 2003 July 2007 Percentage of total incidents November 2003 July 2007 Anti-cancer agent Capecitabine % Mercaptopurine 40 9% Chlorambucil 34 8% Cyclophosphamide 34 8% Etoposide 34 8% Hydroxycarbamide 23 5% Oral anticancer agent (un-specified) 20 4% Melphalan 12 3% Fludarabine 10 2% Lomustine 9 2% Imatinib 8 2% Temozolomide 8 2% Procarbazine 7 2% Tretinoin 6 1% Vinorelbine 5!% Idarubicin 2 <1% Treosulfan 3 <1% Busulphan 1 <1% Tioguanine 1 <1% Mesna 1 <1% Total % Tables 5and 6 do not include incidents concerning oral Methotrexate as these are normally concerned with the use of methotrexate for non-cancer treatment. The NPSA issued guidance concerning the safe use of oral methotrexate in 2004 and again in See NPSA website further details are available at For IMMEDIATE ACTION by the NHS and the independent sector the deadline date for ACTION COMPLETE is (six months after issue) Doctors, nurses, pharmacists and their staff must be made aware that the prescribing, dispensing and administering of oral anti-cancer medicines should be carried out and monitored to the same standard as injected therapy. This requires that: Healthcare organisations should prepare local policies and procedures that describe the safe use of these oral medicines. Treatment should be initiated by a cancer specialist. All oral anti-cancer medicines should be prescribed only in the context of a written protocol and treatment plan. Non-specialists who prescribe or administer on-going oral anti-cancer medication should have ready access to appropriate written protocols and treatment plans including guidance on monitoring and treatment of toxicity. Staff dispensing oral anti-cancer medicines should be able to confirm the prescribed dose is appropriate for the patient, and that the patient is aware of the required monitoring arrangements, by having access to information in the written protocol and treatment plan from 4

5 the hospital where treatment is initiated and advice from a pharmacist with experience in cancer treatment in that hospital. Patients should be fully informed and receive verbal and up-to-date written information about their oral anticancer therapy from the initiating hospital. This information should include contact details for specialist advice, which can be shared with non-specialist practitioners. Written information including details of the intended oral anti-cancer regimen and treatment plan including arrangements for monitoring, taken from the original protocol, should be given to the patient. When shared with pharmacists and dispensing staff, this would enable the above dispensing requirements to be satisfied. Full use should also be made of NHS cancer centre web sites to provide information for healthcare staff, patients and carers to ensure the safe use of oral anti-cancer medicines. The above guidance is primarily intended to promote the safe use of the medicines listed to treat cancer. Where the use of these medicines is for non-cancer treatment, a risk assessment should be undertaken and the guidance applied as appropriate. More information concerning the standards for cancer therapy in England can be found in the NHS Manual For Cancer Services The information in the manual is an integral part of the NHS Cancer Plan and modernisation of cancer services and supports quality assurance of cancer services and enables quality improvement. More information concerning the standards for cancer therapy in Wales can be found What form should the expert guidance from the specialist centre take? Written advice giving clear unambiguous instructions regarding the following: Regimen and doses (including all oral anti-cancer medicines to be used and elective essential support drugs in addition to anti-emetics). Dosing may be mg/kg, mg/m 2 or mg/frequency per day. Route of administration. Number of cycles intended. Frequency of cycles and of administrations within a cycle. Investigations necessary prior to starting the whole course. Monitoring to be performed serially during the course (to detect/monitor both toxicity and response) and their intended frequency. Guidance on management of toxicity and the possible need for dose modifications. For palliative, curative and neo-adjuvant treatments (any treatment other than adjuvant); the maximum number of cycles after which the response to treatment is to be reviewed prior to continuing the course. 5

6 References 1. Partridge, Sylvia Bartel, Lawrence N Shulman and Maureen Connor, Saul N Weingart, Jonathan Flug, Daniela Brouillard, Laurinda Morway, Oral chemotherapy safety practices at US cancer centres: questionnaire survey. BMJ 2007;334: Taylor JA,Winter L,Geyer LJ,Hawkins DS. Oral outpatient chemotherapy medication errors in children with acute lymphoblastic leukemia. Cancer 2006;107: British Oncology Pharmacists Association. Position statement on the care of patients receiving oral chemotherapy. Pharmaceutical Journal 2004; 272:

North of England Cancer Network. Policies and Procedures. Standards for the Safe Use of Oral Anticancer Medicines

\ North of England Cancer Network Policies and Procedures Standards for the Safe Use of Oral Anticancer Medicines NECN Oral Anticancer medicine Policy version 1.6 Page 1 of 17 Issue Date: Feb 2017 Contents