Procedure for the Safe Prescribing, Handling and Administration of Cytotoxic and other Chemotherapeutic Agents CATEGORY: Procedural Document CLASSIFICATION: Clinical PURPOSE This document explains the procedures to be taken by clinical staff within University Hospitals Birmingham NHS Foundation Trust for the safe prescribing, handling and administration of cytotoxic and other chemotherapeutic agents Controlled Document 504 Number: Version Number: 3 DOCUMENT Controlled Document Executive Medical Director Sponsor: Executive Chief Nurse Director of Pharmacy Controlled Document Lead Chemotherapy Nurse Lead: Lead Cancer Services Pharmacist Approved By: MMAG On: December 2014 Review Date: December 2017 Distribution: All Clinical Staff within • Essential University Hospitals Birmingham Reading for: NHS Foundation Trust who are responsible for the Safe CONTROLLED Prescribing, Handling and Administration of Cytotoxic and other Chemotherapeutic Agents • Information for: All Clinical Staff Doc Index No. 504 Version 3 Page 1 of 29 Procedure for the safe prescribing, handling and administration of cytotoxic and other chemotherapeutic agents UNIVERSITY HOSPITALS BIRMINGHAM NHS FOUNDATION TRUST Procedure for the Safe Prescribing, Handling and Administration of Cytotoxic and other Chemotherapeutic Agents Contents Page 1.0 Introduction and aim of the document 5 2.0 Definition 5 2.1 Cytotoxic 5 2.2 Chemotherapy and Chemotherapeutic Agents 6 2.3 Non-cancer cytotoxic drugs used in other clinical settings 6 2.4 Monoclonal Antibodies, fusion proteins and other relevant agents 6 3.0 Risk Management 7 3.1 Risk assessment 7 3.2 Liability 7 3.3 Errors, incidents and near misses 7 4.0 Consent 8 4.1 Patient Information and education 9 4.2 Pre chemotherapy holistic assessment for cancer patients 10 4.3 General Practitioner and District Nurse information 10 5.0 Staff Training 10 5.1 Medical Staff 10 5.2 Nursing Staff 11 5.2.1 Registered Nurses 11 5.2.1.1 Administering intravenous chemotherapy 11 5.2.1.2 Checking intravenous chemotherapy 11 5.2.1.3 Administering and checking of oral chemotherapy 11 5.2.1.4 Intrathecal chemotherapy 12 5.2.2 Non-Registered Nursing Staff 12 5.2.3 Community Nurses 12 5.3 Pharmacy Staff 12 5.4 Patients, Parents and Carers 12 5.5 Porters and Domestic staff 13 6.0 Staff Responsibilities 13 6.1 Medical Staff 13 Doc Index No. 504 Version 2 Page 2 of 29 Procedure for the safe prescribing, handling and administration of cytotoxic and other chemotherapeutic agents 6.1.1 Prescribing 13 6.2 Nursing Staff 13 6.2.1 Registered Nurses 13 6.2.2 Non-Registered Nursing Staff 14 6.3 Pharmacy Staff 14 6.3.1 Prescription safety 14 6.3.2 Safe and Accurate compounding of cytotoxic drugs 15 7.0 Pharmacy Services 15 7.1 Purchasing, Receipt and Storage 15 7.2 Reconstitution 15 7.3 Dispensing 16 8.0 Prescribing of chemotherapy 17 8.1 Intrathecal Prescribing 17 8.2 Computer generated prescriptions 17 8.3 Prescription details 17 8.4 Authorised Regimens 18 8.5 Advance Prescribing 18 9.0 Safe Handling of Cytotoxic Materials 18 9.1 Personal Protective Equipment (PPE) 18 9.1.1 Disposable nitrile gloves 18 9.1.2 Eye and face protection 19 9.1.3 Respiratory protection 19 9.1.4 Aprons and Armlets 19 9.2 Oral dosage forms of cytotoxic drugs 19 9.3 Staff 20 9.3.1 Pregnant staff 20 9.3.2 Students 20 9.3.3 Health screening 20 9.4 Pathological samples and body waste 20 10.0 Disposal of Cytotoxic Materials 20 10.1 Disposal of equipment that contains NO visible residual 20 chemotherapy 10.2 Disposal of equipment that contains ANY visible residual 21 chemotherapy Doc Index No. 504 Version 2 Page 3 of 29 Procedure for the safe prescribing, handling and administration of cytotoxic and other chemotherapeutic agents 10.3 Non-disposable equipment 21 10.4 Pathological samples and body waste 21 10.5 Unused or out of date drugs 21 10.6 Collection of waste 21 11.0 Extravasation 22 12.0 Spillage / contamination of skin / mucous membrane 22 13.0 Administration 22 14.0 Administration equipment 22 15.0 Audit 22 16.0 Associated Documents 22 17.0 References and Bibliography 23 Appendix Table 1: Cytotoxic drugs and substances 27 1 Table 2: Monoclonal Antibodies, fusion proteins and other 28 relevant agents Appendix Table 3 PPE to be used when handling cytotoxics 29 2 Doc Index No. 504 Version 2 Page 4 of 29 Procedure for the safe prescribing, handling and administration of cytotoxic and other chemotherapeutic agents 1.0 Introduction and aim of document Many Cytotoxic and other Chemotherapeutic Agents have been shown to be mutagenic, teratogenic and carcinogenic. Occupational exposure to Cytotoxic and other Chemotherapeutic Agents presents a significant danger to healthcare staff and unwarranted handling of these drugs should be avoided (Meade 2014) Evidence suggests that safe handling measures are effective in achieving a reduction in exposure levels. In line with the Control of Substances Hazardous to Health (COSHH) regulations, guidance is needed in the safe-handling practices to minimise staff exposure to cytotoxic agents. In addition, risks to patients from incorrectly prescribed and administered chemotherapy are well documented. Risks to patients are minimised when chemotherapy is delivered by informed staff, adhering to evidence based practice guidelines (COSHH 2002 6th Ed, HSE 2003, NCAT 2011, 2012 & BOPA 2013.) The aim of this document is to set out the safe procedure for the prescribing, handling and administration of cytotoxic and other chemotherapeutic agents within University Hospitals Birmingham NHS Foundation Trust (UHB). It is intended to safeguard patients, staff and visitors, by defining acceptable standards of practice for all disciplines involved in cytotoxic and non-cytotoxic chemotherapy. To ensure the highest standard of safety for patients, staff and visitors within UHB, the Trust should concentrate activities involving chemotherapeutic drugs and cytotoxic agents to appropriately trained, staffed and equipped areas using standardised procedures. Where relevant, compliance with the Manual of Cancer Measures (2014), which is subject to Peer Review, has been incorporated into this procedure. Although the measures were not intended to apply in the non-cancer setting, the principles should be considered good practice in any arena where cytotoxic drugs or chemotherapeutic agents are used. In addition health and safety and safe handling concerns apply to cytotoxic drugs regardless of the disease for which they are being used, and therefore these procedures should be considered applicable Trust wide. For clarification on which drugs and which setting require compliance with policy see section 2 – Definitions, and section 3 Risk Management. 2.0 Definitions 2.1 Cytotoxic The word ‘cytotoxic’ literally means ‘kills cells’. However, the term ‘cytotoxic’ is generally used to denote an agent that may be genotoxic, oncogenic, mutagenic or teratogenic (HSE 2003) by virtue of its effect on DNA production or function. The drugs or substances listed in Table 1 (Appendix 1) are to be considered as ‘cytotoxic’ within the terms of this document as they require safe handling measures to protect staff and patients from potential hazards caused by the drugs effects on DNA function, regardless of the disease to be treated. Doc Index No. 504 Version 2 Page 5 of 29 Procedure for the safe prescribing, handling and administration of cytotoxic and other chemotherapeutic agents 2.2 Chemotherapy and Chemotherapeutic agents For the purpose of this document, chemotherapy is a collective term used for the treatment of cancer with drugs. A chemotherapeutic agent is one of those drugs used in chemotherapy to treat cancer with the specific action of killing cancer cells or controlling cancerous cell growth. The term,‘chemotherapy’ or ‘chemotherapeutic agent’ includes drugs considered cytotoxic (i.e. those listed in Table 1 Appendix 1) but also includes drugs such as monoclonal antibodies and other relevant agents e.g. signal transduction inhibitors (see Table 2, Appendix 1), when used to treat cancer. In the latter case handling hazards to staff are absent or less clearly defined or evaluated. Non-cytotoxic chemotherapeutic agents may not require compliance with the safe handling aspects of this document but will require compliance with other aspects relating to safe prescribing and patient care. See section 3 - Risk Management 2.3 Non - cancer cytotoxic drugs used in other clinical settings Non-cancer cytotoxic drugs may be identified from time to time and examples include: • Ganciclovir administered throughout the Trust for cytomegalovirus (CMV) Infections in immuno-compromised individuals. • Azathioprine a precursor of 6- mercaptoputine used as an immunosuppressant in a wide variety of diseases. These drugs are considered cytotoxic and potentially teratogenic, and carcinogenic. Therefore they should be handled in accordance with the safe practice guidelines as outlined in this document. 2.4 Monoclonal Antibodies, fusion proteins / and other relevant agents Reference should be made to the Trust Guidelines for the risk assessment of the Safe Handling and Administration of Monoclonal Antibodies and Related Products (current version) for specific guidance and Pan Birmingham Guidelines for the Preparation or Manipulation of Monoclonal Antibodies Used in the Treatment of Cancer (Current version). These drugs are administered for a variety of malignant and non-malignant medical conditions. Intravenous administration of monoclonal antibodies, fusion proteins / and other relevant agents can only be