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Cytotoxic Drugs for Adult Patients in Oncology and Haematology Version: 9 Issue Date: 21 November 2019 Review Date: 20 November 2021 (unless requirements change) of 41

POLICY FOR SYSTEMIC ANTI CANCER THERAPY FOR ADULT

PATIENTS IN ONCOLOGY AND HAEMATOLOGY: PRESCRIBING, HANDLING AND ADMINISTRATION.

Version 9

Name of responsible (ratifying) Committee Formulary and Medicines Group

Date ratified 11 October 2019

Document Manager (job title) Lead Chemotherapy Nurse

Date issued 21 November 2019

Review date 20 November 2021

Electronic location Clinical Policies

Related Procedural Documents -

Key Words (to aid with searching) Cytotoxic, Chemotherapy, Oncology, Haematology, Oral, Intravenous, Subcutaneous, Teratogenic, Safe Handling, COSHH, Vesicant

Version Tracking Version Date Ratified Brief Summary of Changes Author

9 11/10/19 Changed to NHSE Quality Surveillance Programme from 2009 Quality & Excellence report. 6.1 Pregnancy recommendations updated. References updated

M. Tonge

8 17/03/17 Section 5 – Added section on training requirements for locums to prescribe chemotherapy.

Section 6 – Added immunotherapy to types of chemo and where they can be administered

Section 10 – Lead Consultant name updated from Dr S Muthuramalingam to Dr S Ellis and Dr C Chau

C Watkinson


CONTENTS

QUICK REFERENCE GUIDE....................................................................................................... 3

1. INTRODUCTION.......................................................................................................................... 4

2. PURPOSE ................................................................................................................................... 4

3. SCOPE ........................................................................................................................................ 4

4. DEFINITIONS .............................................................................................................................. 4

5. DUTIES AND RESPONSIBILITIES .............................................................................................. 5

6. PROCESS ................................................................................................................................... 9

7 TRAINING REQUIREMENTS .................................................................................................... 23

8. REFERENCES AND ASSOCIATED DOCUMENTATION .......................................................... 24

9. EQUALITY IMPACT STATEMENT ............................................................................................ 24

10. MONITORING COMPLIANCE WITH PROCEDURAL DOCUMENTS ........................................ 26

APPENDIX 1: .................................................................................................................................... 27

APPENDIX 2: .................................................................................................................................... 28

APPENDIX 3: .................................................................................................................................... 29

APPENDIX 4: .................................................................................................................................... 30

EQUALITY IMPACT SCREENING TOOL ......................................................................................... 40


QUICK REFERENCE GUIDE This policy must be followed in full when developing or reviewing and amending Trust procedural documents. For quick reference the guide below is a summary of actions required. This does not negate the need for the document author and others involved in the process to be aware of and follow the detail of this policy.

1. Systemic Anti Cancer Therapy (SACT) should only be administered if prescribed on Aria e-prescribing platform unless the regimen required is not available, in which case the correct prescription with all the appropriate information and supporting evidence i.e. blood results, performance status, consent etc. available.

2. Only staff who have received appropriate training and are either working under direct or indirect supervision or are deemed competent should administer chemotherapy.

3. Patients must be told to inform a member of staff if, at any time the infusion is painful or they feel unwell in any way.

4. Before administering chemotherapy staff need to ensure they have correctly identified the patient and consent has been obtained.

5. All patients must be reviewed clinically prior to the administration of cytotoxic chemotherapy. For day 1 of a cycle patients must be reviewed by the prescriber or their appointed deputy. For subsequent days of treatments e.g. Day 8 and / or 15 this review may be carried out by a nurse. In all cases this review for ‘fitness to proceed’ must be documented in the patient’s healthcare record.


1. INTRODUCTION Portsmouth Hospitals NHS Trust (PHT) is committed to safeguarding patients, staff and others who may come into contact, either directly or indirectly with cytotoxic drugs. Cytotoxic drugs work directly or indirectly by causing cell death and may be mutagenic, teratogenic and carcinogenic. Their inherent toxicity has led to concerns over the potential hazards to health workers and other personnel who may be exposed to them. It is essential that safe practices and high standards of care are maintained at all times. These practices are guided by national policy and guidelines which shape the practice at PHT. Each year a self assessment against national guidelines is completed and uploaded to the NHS England Quality Surveillance Program. This is based on the Achieving World-Class Cancer Outcomes cancer strategy (2015-2020)

2. PURPOSE The purpose of this policy is to: • Provide a clear framework and guidance for the safe prescribing, handling and administration

of cytotoxic drugs to adult patients within the departments of Oncology and Haematology. • To ensure a consistent approach to the prescribing, handling and administration of cytotoxic

drugs to adult patients within Oncology and Haematology. • To ensure that all members of staff involved in any stage of the process of preparation,

handling, administration or disposal of SACT or the handling of equipment used in their preparation, administration or disposal should be adequately prepared and trained appropriate to their level of need.

3. SCOPE

All staff employed by the Trust who have contact with cytotoxic drugs and/or provide care to patients receiving treatment with cytotoxic drugs within the departments of Oncology and Haematology at Queen Alexandra Hospital will adhere to this policy. This will include doctors, nurses (including both those professionally qualified and unqualified students and Health Care Support Workers), pharmacy professionals, technical staff, facilities management and clerical staff working in the relevant areas. Staff providing a chemotherapy outreach service to St Richard’s Hospital Chichester will abide by St Richard’s local policies and guidelines. All aspects of this policy and associated documents apply to both solid tumour Oncology and Haematology adult patients unless otherwise specifically stated. ‘In the event of an infection outbreak, flu pandemic or major incident, the Trust recognises that it may not be possible to adhere to all aspects of this document. In such circumstances, staff should take advice from their manager and all possible action must be taken to maintain on-going patient and staff safety’

4. DEFINITIONS The term “cytotoxic drug” is generally used for agents which are toxic to cells and hence can be used in the treatment of cancers and in some non-malignant conditions such as rheumatoid arthritis. Systemic Anti -Cancer Therapy (SACT) is another commonly used term to describe the medicines given to cancer patients as part of their treatment. It includes cytotoxic chemotherapy drugs and immune response modifying drugs. This term is increasingly used to cover all treatments covered in this policy.


COSHH (Control of Substances Hazardous to Health) regulations under the Health and Safety at Work Act (1974) places a duty of care on all employers to ensure that measures are in place to reduce the potential risks to staff and other personnel. Extravasation. This is the inappropriate or accidental administration of chemotherapy into the subcutaneous or sub-dermal tissues rather than into the intravenous compartment.

5. DUTIES AND RESPONSIBILITIES

Head of Chemotherapy Services • The Head of Chemotherapy Services will ensure PHT has an appropriate policy

for the safe handling and administration of chemotherapy and is responsible for ensuring implementation and adherence to this policy.

• Role and Responsibilities: see Appendix 1

Lead Nurse for Chemotherapy • Overall responsibility for training, health and safety. • Role and Responsibilities: see Appendix 2

Lead Oncology / Haematology Pharmacist

• Overall responsibility for clinical issues relating to SACT • Responsibilities: see Appendix 3

Prescribers (including non-medical prescribers) In keeping with the National Chemotherapy Advisory (NCAG) recommendations (2009) the decision to treat a patient with SACT should be made following an open discussion between the patient and their consultant. Treatment options should be in line with standard practice and must be discussed at an appropriate Multidisciplinary Team Meeting (MDT). This decision must take into account what is believed to be in the best interest of the patient.

Prescribers who are able to prescribe Chemotherapy Only appropriately qualified and competent clinicians, who have successfully undertaken agreed training, are able to initiate and prescribe courses of SACT for treatment of cancer patients. These include: • Consultant Medical Oncologists • Consultant Clinical Oncologists • Consultant Haematologists • Staff Grade Registrars at level ST3 and above, within the agreed competency framework • Non-medical prescribers who are registered at PHT and within their agreed scope of competency. Non-medical prescribers cannot prescribe the first cycle of SACT. (See further information below). The prescriber should inform the patient’s general practitioner of the intention to start the course of chemotherapy and provide sufficient information for action to be taken in the event of the patient experiencing side effects.

Prescribing of second or subsequent cycles may be delegated to Specialist Registrars in training (ST3 or above) or non-medical independent prescribers who have completed the necessary training, are registered with their professional body and are authorised by PHT to prescribe within their competence. Delegation of this responsibility is only permitted if the relevant Consultant has given clear written details of the patient’s treatment plan, documented this in the patient’s healthcare record and if the regimen being prescribed is included in the PHT agreed list of regimens. If modifications of doses are required, the Consultant or the Specialist Registrar in training (ST3 or above) must document this in the healthcare record. For non-medical prescribers, if such modifications are outlined in the patient’s protocol then the same applies.


Locum doctors must be of the equivalent level to those doctors listed above (ST3 and above). All locum doctors including Consultants must have their competency assessed and be signed off. The form that is required to be signed is the same as that used for doctors in training. (See appendix 4 p.32 for copy of Form: Prescription of systemic anti-cancer competency assessment) locum Consultants are required to be signed off by another Consultant working in that tumour site area and this should be counter signed by the Clinical Director for Oncology or the Lead Clinician for Chemotherapy. Pharmacy will not screen prescriptions for locums unless this form has been completed. Without this a second signature from a registered PHT prescriber would be required. Medical doctors who are provisionally registered with the GMC (FY1) and F2/ Core trainees MUST NOT prescribe SACT for the treatment of malignant disease. Non-medical prescribers authorised to prescribe medicines at PHT will be included on a Trust register of non-medical prescribers. Non-medical prescribers must comply with the PHT Medicines Management Policy and related codes of practice. Non-medical prescribers may only prescribe medicines for NHS patients under the care of PHT within the specialty in which they have demonstrated competence. Non-medical prescribers will be expected to recognise those situations where it is inappropriate for them to prescribe.

The non-medical prescriber is accountable for: • The assessment of patients with diagnosed or undiagnosed conditions and for decisions

about the clinical management required, including prescribing. • Carrying out reviews of the patient’s progress at regular intervals, including the recording

of performance status, investigational results and serious toxicities following a previous cycle of SACT, depending on the nature and stability of the patient’s condition.

• Identifying possible drug related adverse incidents and reporting them via the PHT Datix scheme and where appropriate to the MHRA via the Yellow card scheme.

• Accepting professional accountability and clinical responsibility for their prescribing.

All prescribers are responsible for: • Checking the allergy status of the patient and checking for any potential interaction

between patient’s current medicines and their SACT or supportive care medicines. • Confirming the appropriate regimen from the agreed list of regimens for the tumour site

concerned. • Where appropriate completing any necessary processes to secure Cancer Drugs Fund

approval. • Ensuring that the body surface area (BSA) calculations are appropriate and have been

made using a recent weight. • Amending doses in line with agreed dose banding agreements. • Prescribing and monitoring of all cytotoxic drugs and supportive therapies including

antiemetics and hydration. This includes the on-going monitoring of toxicities and amendment of supportive medicines where required.

• Ensuring that maximum cumulative doses of anthracyclines and bleomycin have not been exceeded.

• Specifying the route of administration and for parenteral doses, the duration of infusion on the prescription.

• Undertaking a preliminary assessment of venous access prior to prescribing infusions of vesicants.


• Ensuring there is an appropriate interval between each treatment day and cycle within the course, as defined by the protocol.

• Ensuring the patient is given written information regarding the SACT treatment they will be given.

• Ensuring the patient is fully informed of their treatment and has given consent. • Ensuring the patient’s treatment plan is summarised and sent to their GP, prior to starting

a course of treatment. The plan should include details of: • Treatment regimen • Planned duration • Treatment intent: palliative, curative, adjuvant, neo-adjuvant, other • Planned start date, if known • Ensuring that all relevant safety parameters such as blood counts, renal and hepatic

function have been checked and that the patient is fit to receive treatment. If doses are modified due to variance of these parameters, the reason for dose modification should be recorded on the prescription and in the patient’s healthcare record.

• If a patient is to be treated with a chemo-radiation protocol it is essential that this is clear on the prescription.

• If the patient is to be treated ‘off-protocol’ then the necessary form must be completed and approved. (Available from pharmacy pages on intranet.)

• Wherever possible, chemotherapy should be initiated during normal working hours when access to specialist staff is more likely to be available. Only in exceptional circumstances may chemotherapy be initiated outside of normal working hours.

• Prescriptions for all cytotoxic drugs should be produced electronically on Aria (or pre-printed proforma for those not available on Aria), not verbally, and changes to any prescriptions must be documented electronically or in writing and signed and communicated to all those necessary – specifically pharmacy.

• Ensuring pre-prescription of the majority of elective IV chemotherapies preferably 48 hours prior to treatment so that doses can be prepared in advance of patients attending for treatment.

• Alerting the pharmacy in the event of re-issuing an already fully-authorised treatment where there have been changes made to drugs or doses (i.e. not just a change in date).

• After the final cycle within a given course, the prescriber should ensure that there is a treatment record for each patient stating whether the course was completed or not. If the course was not completed, the reasons for early cessation should be documented. For completed courses of non-adjuvant treatment, a reference to the response should be documented.

• An ‘End of treatment’ summary should be offered to the patient and sent to the patient’s GP and any other relevant health care professionals.

Registered Nursing Staff • To ensure that they undertake training and achieve and maintain competency in SACT

administration. • Correct storage of drugs before use. • Clarify that the prescription chart is completed correctly and that blood results are double-

checked and are satisfactory before proceeding. • Confirm that the patient has consented to SACT treatment. The nurses must double-

check the consent form and discuss the side effects of SACT with the patient and give the patient a copy.

• Ensure that the patient is fit to receive SACT by checking the patient’s performance status and that their clinical status has not changed since the last medical review.

• To undertake a holistic assessment. • To administer the correct prescribed drug and dose to the right patient. • To carefully monitor the patient during the administration of drugs being vigilant to observe

any signs of extravasation, severe allergic reactions, fluid overload, etc.


• To make appropriate referrals and provide patient information regarding the treatment and any side effects during and following treatment.

• To provide a HEAT card containing key information about contact details in case of emergency and written information about the side effects of SACT.

• To document the administration of SACT including any adverse events. • To rehearse with patients what they should do in the event of developing a complication.

This should include consideration of which hospital they would attend and how they would get there both during and out of working hours.

• Liaising with the community nursing team and/or key worker as appropriate to ensure ongoing support.

Unregistered Nursing Staff (students and Health Car e Support Workers) • To provide support to trained staff in the performance of their duties. • To be aware of and observe appropriate precautions when handling contaminated

equipment and waste including body fluids.

Pharmacist Responsibilities An appropriately trained pharmacist who is accredited and on the Trust register, must clinically screen all prescriptions for SACT intended for the treatment of malignant disease and document that the prescription has been clinically screened.

Prior to a cytotoxic dose being prepared the pharmacist must verify the prescription according to the protocol or treatment regimen, clarify and resolve any discrepancy and check:

• The appropriate regimen / protocol / proforma has been selected, with correct sequencing. • If an ‘off protocol’ regimen is prescribed that the necessary paperwork and approval is in

place. • When required that approval for funding is in place e.g. Cancer Drugs Fund. • The route of administration and duration of infusion have been specified on the

prescription. • Most recent blood results (no more than 72 hours old for 3 weekly SACT and no more

than 24 hours for weekly and day 8 SACT) and liaise with clinicians if results are outside of the normal range.

• Dose modifications are applied and appropriate and that when required are maintained for subsequent cycles (as necessary).

• Administration details are correct for the chosen protocol, that the duration of treatment is appropriate and associated treatments e.g. anti-emetics, hydration are prescribed.

• The interval between treatment and cycles is appropriate. • That maximum cumulative doses for anthracyclines and bleomycin have not been

exceeded. • Safe and accurate compounding of SACT, including drug/ drug, or drug /vehicle

compatibility, labeling, determination of expiry and storage conditions and appropriate presentation of the drug.

• All relevant documentation is completed. • All SACT regimens comply with agreed protocol/network approved list. Discrepancies or

pharmacist queries should be discussed with the appropriate consultant.


6. PROCESS Table 1: Areas where staff are competent to adminis ter chemotherapy

Location Types of chemotherapy administered

Oral Intravenous Subcutaneous/ Intramuscular

Immunotherapy Intrathecal

Queen Alexandra Hospital

Haematology/ Oncology Day Unit

Yes Yes Yes Yes Yes Procedure Room 4 (B1312)


Haematology/ Oncology Out- patient Clinic Rooms

Yes No Yes – specifically monoclonal antibodies

No No


Haematology/ Oncology wards F5/F6/F7

Yes Yes Yes Yes Yes Room (F1321)


Renal In-patient wards

Yes No Yes No No


Theatre No Yes – Specifically electrochemo-therapy and intravesical*

No No No

*A separate policy exists to ensure safe prescribing, dispensing, delivery and administration of intravesical chemotherapy within the Department of Urology. This policy does not apply to areas where cytotoxic agents are used for non-malignant conditions where such practice is governed by local/department policies and guidelines

Chemotherapy administration should only be carried out in the areas defined in table 1. These are areas where there are nursing staff competent in the administration, care and management of side effects of the chemotherapy treatments in use. All these clinical areas will be provided with the appropriate protective clothing and equipment. Areas will have available to them details of the regimens and protocols in current use. Although Renal and Theatres are listed as an appropriate area it must be chemotherapy trained nurses who administer the medicines. This must be arranged directly with the Sister of HODU or the Bleep holder for F level (bleep 0070).

In exceptional circumstances cytotoxic drugs may be required to be administered outside a designated area, for example ITU and the medical floor. If this situation does arise: • This must be agreed by the prescribing oncologist / haematologist, the oncology

pharmacist, a senior chemotherapy nurse and the medical and nursing staff of the area concerned.

• The prescriber and lead / senior chemotherapy nurse must ensure that the chemotherapy is given by fully trained chemotherapy nurses, and that the staff caring for the patient will receive appropriate explanation and training regarding post-chemotherapy aftercare.


• Relevant policies and treatment protocols must be available. • All relevant equipment (cytotoxic spillage kit, bins etc) must be provided.

Emergency Administration Out-of-Hours Pharmacy will accept requests for chemotherapy treatment between the hours of 0800 – 1700 hours (Monday to Friday). On the Haematology/Oncology day unit whenever possible chemotherapy should be administered / commenced during the normal working day i.e. 0800 – 2000 hours (Monday to Friday) to ensure access to support services, key personnel and clinical expertise is available. On F-Level (Haematology/Oncology wards) initiation of inpatient cytotoxic chemotherapy must whenever possible be undertaken during the normal day time hours (Monday to Friday 0800 to 1800). There is always at least one member of staff on duty on F-level who is chemotherapy trained. The exceptions are: Continuous infusions Regimens where cytotoxic chemotherapy is administered for consecutive days Timed cytotoxic chemotherapy Cytotoxic chemotherapy given more than once a day Emergency cytotoxic chemotherapy Planned chemotherapy activities on Saturday: To cope with the demand and also to ease the pressure during long holiday periods over Easter and Christmas, elective chemotherapy and supportive treatments may need to be delivered on a few Saturdays in a year. The following criteria must be met before planning these activities on Saturdays:

1. There is sufficient medical support available to safely manage the patient. 2. There are appropriately trained nursing staff to safely administer chemotherapy. 3. The pharmacy department has sufficient capacity to safely prepare and dispense the

chemotherapy. 4. All chemotherapy patients should be ideally pre-assessed and all chemotherapy pre-

prescribed before Saturday.

Whenever possible the decision to treat adult patients with chemotherapy should be made, and treatment initiated, within normal working hours. Wherever possible patients should be given other supportive therapies to permit the administration of parenteral chemotherapy to take place during normal working hours. e.g. for a patient with newly diagnosed acute leukaemia – hydroxycarbamide to reduce the white cell count, alongside hydration and allopurinol (300mg PO od) to protect against tumour lysis syndrome; for newly diagnosed aggressive lymphoma - high dose steroids (e.g. 1g methylprednisolone IV), alongside hydration and allopurinol (300mg PO od) to protect against tumour lysis syndrome. In exceptional circumstances, it may be clinically indicated that emergency cytotoxic chemotherapy should be initiated outside normal working hours. In such a circumstance a decision to treat must be made by the consultant Oncologist/Haematologist in conjunction with a senior member of the nursing team and on call pharmacy staff. The following situations have been agreed where the supply of out-of-hours chemotherapy would be deemed essential. These protocols are available on the Intranet on the pharmacy pages http://pharmweb/Publications/Oncology/charts.aspx?id=Out%20of%20Hours%20Chemotherapy Adult Haematology:


1. Acute Myeloid Leukaemia (AML): Unanticipated admission of a newly diagnosed patient with a high white cell count or clinically unwell.

2. Acute Promyelocytic Leukaemia (APML) 3. Acute Lymphocytic Leukaemia (ALL) 4. Non-Hodgkin’s Lymphoma (NHL): if tumour threatening function of a vital organ e.g.

tracheal, ureteric obstruction. 5. Anthracycline extravasation

Adult Oncology: 1. Small Cell Lung cancer (SCLC): with superior vena cava obstruction or Metastatic

Spinal Cord Compression (MSCC) 2. Anthracycline extravasation

Medical Responsibilities The patient must be reviewed by a consultant oncologist or haematologist. They should endorse the decision to start chemotherapy in writing in the patient’s case notes.

A consultant or specialist registrar must contact the on-call pharmacist to discuss the need for chemotherapy out-of-hours. The on-call pharmacist may wish to refer the call to a more senior colleague or an oncology/haematology pharmacist. The consultant or SpR must complete all sections of the ‘Request for Essential Out-of Hours Chemotherapy’ form and return it to the on-call pharmacist.

The consultant must: Ensure that there is sufficient medical support available to safely manage the patient over the weekend. Ensure that there are appropriately trained nursing staff on all shifts over the weekend during which the patient will receive chemotherapy The consultant or specialist registrar (SpR) must prescribe the full course of chemotherapy using one of the approved pre-printed prescriptions relevant to their area.

Pharmacy Responsibilities: A pharmacist will discuss the need for chemotherapy with the requesting consultant. Once the pharmacist has agreed that chemotherapy will be provided they will make arrangements for it to be prepared. The pharmacist will check that the consultant or specialist registrar has completed the ‘Request for Essential Out-of Hours Chemotherapy’ form. The pharmacist will check the prescription and that the doses have been calculated correctly. Any issues will be resolved with the prescriber before preparation of the chemotherapy. Once the chemotherapy has been prepared it will be sent to the appropriate ward. If chemotherapy has been ordered in anticipation of a patient deteriorating further the chemotherapy will be retained in pharmacy until the patient is ready to receive treatment. Request for Essential Out-of Hours Chemotherapy To be completed by the prescribing consultant or specialist registrar.


The consultant or specialist registrar will be taking full responsibility for the clinical assessment of the patient.

Patient Name: Hospital Number: Date of Birth: Or attach addressograph label Ward: Consultant:

Chemotherapy Details

Regimen requested

Disease state / reason for request Full cycle of chemotherapy required Y/N

Day 1 only required Y/N

Chemotherapy prescribed by (consultant or SpR only)

Signature of consultant Print name

Designation

Date

Signature of Pharmacist Print name

Designation

Date


6.1 HEALTH & SAFETY

• Cytotoxic drugs are classed as substances that pose a serious risk to health and are

therefore subject to COSHH regulations.

Risk Assessment and Risk Management

• A register of all staff involved in the handling of cytotoxic drugs must be kept by the manager of each area involved.

Pregnancy and Breastfeeding

It is widely accepted that staff handling Systemic Anti Cancer Therapy are exposed to the agents at key points during the process, especially if control measures are not adhered to. Adverse effects on the foetus as a result of the mother working with cytotoxic drugs is documented and supported through theoretical models. The literature available acknowledges its limitations, as there is no accepted exposure level and due to the nature of the drugs it is impossible to test hypotheses. It is generally accepted there is a risk, that the rates of miscarriage are higher amongst mothers who handled SACT. The risk to the foetus is greatest during the first 12 weeks of pregnancy. As the pre-conception period is not included in any health and safety advice, managers must ensure that a COSHH (Control of Substances Hazardous to Health) assessment is carried out in all areas where cytotoxic drugs are handled in order to assess the level of risk and the adequacy of control measures in place. Directions on how risk assessments can be completed can be found at http://www.hse.gov.uk/risk/index.htm. The risk assessment should assume that there may be a new or expectant mother working in the environment in the following 12 months. Precautions must be in place at all times to minimize exposure by using protective garments, appropriate equipment, as well as safe and validated work practices. This applies to both male and female staff exposed to both investigational agents and licensed drugs. As some pregnancies are unplanned, or staff may be unwilling to discuss plans for conception, the emphasis must be on the reduction of exposure to all staff at all times. This policy aims to reduce the risk of exposure to these drugs as far as possible. However, as there is no known limit where exposure is thought to be safe, employees must be informed of the potential reproductive risks. Employees should notify their managers as soon as possible if they are pregnant, trying to conceive or breast feeding. This is particularly important as the greatest risk is during the first three months of pregnancy, when rapid cell division and differentiation occurs. This is also to comply with HSE guidance stating that all pregnant staff, or those trying to conceive, should be removed from duties involving the preparation of cytotoxic drugs. At the point where an employee discloses pregnancy, a risk assessment specific to the individual should be carried out and any appropriate action taken.

All staff should be fully informed of the reproductive risks by:

• Receiving verbal and written information on induction • Signing to say they have read and understood the relevant risk assessments • Providing opportunities for discussion of any concerns

Pregnant or breastfeeding staff will be expected to make an informed choice about working with cytotoxic drugs. Staff who choose not to work with cytotoxic drugs will not be expected to be


involved in directly preparing or administering chemotherapeutic agents or handling waste from patients treated with SACT. If appropriate, the line manager and Human Resources Department will agree any new temporary arrangements together with the member of staff and ensure that she is adequately supported during her pregnancy. New, expectant and breastfeeding mothers should be specifically advised against any direct involvement in the management of a cytotoxic drug spillage. Monoclonal Antibodies (MAbs) Monoclonal antibodies affect a range of biological functions and staff handling them should be aware of the nature of each product and specific associated problems. As these agents may contain material of animal origin, they are potentially biohazardous and so direct handling should be minimized and protective clothing worn to the same level as for traditional cytotoxic medicines. There is also a theoretical risk of operator sensitization as MAbs are proteinaceous in nature and staff should be made aware of this. The preparation of MAbs should be individually risk assessed, taking into account the allergic potential based on the origin of the MAb and toxicities arising from the therapeutic use. Together with the NPSA risk assessment tool for intravenous medicines, an overall risk could then be used to decide whether manipulation should be within an aseptic unit (high risk) or permitted in a clinical area, using appropriate closed system transfer devices. Administration of MAbs

Although full Systemic anti cancer therapy nurse administration training is not required for the administration of MAbs they have specific toxicity and administration risks associated with them. All nursing staff who are required to administer these drugs but who have not completed full cytotoxic training may be assessed by the Clinical Educator for Oncology. A register of these nurses will be held and maintained by the clinical educator in addition to the full chemotherapy trained register. Suitability to remain on this Moncolonal Register will be assessed annually.

6.2 STORAGE AND TRANSPORTATION OF CHEMOTHERAPY

Storage

• Pharmacy staff are responsible for correct storage of drugs prior to delivery to wards. • Bags or boxes should not be left unattended or with untrained staff on arrival. • Access to cytotoxic agent storage areas must be limited to authorised staff. • Cytotoxic drugs should be stored in a safe, accessible area at the lowest level of practical

shelf storage. • Careful layering should be used to avoid undue stress and pressure on the packaging. • Nurses are responsible for correct storage of drugs delivered to wards and clinics and

appropriate monitoring of storage facilities. • Cytotoxic agents must be stored separately from other drugs • Parenteral doses of SACT should be stored in a designated locked fridge or locked

cupboard. • Oral doses must be stored in a designated locked trolley, fridge or cupboard. • Any refrigerators used for the storage of SACT doses should be monitored daily to ensure

that the temperature is maintained between 2 to 8 degrees centigrade. Transportation

• All cytotoxic drugs are clearly labeled as such and must be transported from pharmacy directly to the designated areas in an appropriately labeled and sturdy transportation bag.

• If the product(s) requires refrigeration, the cold chain should be maintained.


• All Trust staff involved in the transportation of SACT drugs must be trained to follow the ‘Cytotoxic Spillage’ guideline.

6.3 MINIMISING EXPOSURE

Clothing

The following guidance applies to all staff handling cytotoxic drugs during administration of treatment, handling of patient waste and cleaning of spillages. • Gloves: Nitrile synthetic rubber gloves must be worn at all times. No glove is completely

impervious to cytotoxic drugs. Gloves must always be changed between patients, and immediately if damaged or if significant contamination occurs. Standard infection control procedures should be followed.

• Gowns: A plastic apron is to be worn at all times during administration. • Eye protection: Goggles must be available and may be worn when reconstituting SACT or if

a spillage occurs. • Masks: Should be available and must be worn whenever there is a possibility of inhaling

droplets.

Equipment

Available at each area will be:

• Extravasation kit, hot and cold packs. • Eye wash kits. • Spillage kit. • Cytotoxic waste bins, bags and sharps boxes. • Protective clothing. • Cardiac arrest trolley. • Equipment and drugs for management of anaphylactic shock. • Blood pressure / thermometer / pulse oximeter. • Paxman scalp cooler (oncology only). • Syringes – must always be luer lock. • Administration sets. Plum A+ luer lock SACT giving sets are to be used • Infusion pumps.

Spillage

Detailed spillage guidelines are available via PHT Drug Therapy Guidelines home page “Guidance on managing a cytotoxic spillage”

• Managers must ensure that all staff are made aware of the spillage procedures that must be adopted and the protective clothing that must be worn.

• A cytotoxic drug spillage kit is available in all designated areas • All spillages of cytotoxic drugs involving staff or patients must be reported using the

standard Safety learning event form and processed as per the Safety Learning Event and near Misses Management Policy.

• Patients will be educated regarding potential spillage management when being discharged with infusion devices.

Handling Waste and Waste Disposal

When dealing with patient waste and other contaminated waste, the following approaches must be used: All staff who handle cytotoxic drugs, waste or work in areas where they are used, must have been appropriately trained/educated, supervised and updated regarding:


• The risks of handling and disposing of waste. • Appropriate practices for handling and disposing of waste. • Local policies and protocols, legal requirements, and the principles behind them.

It is the responsibility of clinical staff to ensure that in any environment where SACT is administered; the drug is kept safely and securely stored, and disposed of correctly – thus causing no danger to any staff working in the area. Only staff who have received information and training regarding waste disposal of cytotoxic drugs should dispose of cytotoxic drugs. On no occasion should staff who haven’t received training be expected to deal with this special waste.

Equipment Waste

• Contaminated materials such as bottles, vials and other materials used in the preparation and administration of cytotoxic agents must be placed in a cytotoxic sharps bin. These are sealed, taped with cytotoxic tape when full and labeled with the name of the clinical area. Also placed in the cytotoxic sharps bins are contaminated needles, syringes, giving sets and tubing which should be disposed of intact.

• Personal protective equipment i.e. gloves, aprons, etc. should be disposed of in a cytotoxic waste bag (yellow with a purple stripe) or purple lidded waste bin labeled cytotoxic.

• The method for disposal of hazardous waste is by incineration. Waste should be segregated and should not be allowed to accumulate. The integrity of the packaging should be safeguarded during storage and transport and should not expose personnel to any risk.

Patient Waste

• Personnel disposing of patient waste should wear gloves and aprons. • Urine, sweat, faeces and vomit may contain high concentrates of cytotoxic or active

metabolites for up to seven days after treatment has stopped. As a general rule, most patient waste can be hazardous for up to 48 hrs.

Cleaning

• Contaminated equipment, such as ambulatory pumps, must be cleaned with Clinell detergent wipes and disposed of appropriately, according to the PHT Medical Devices Management Policy, by trained staff who are aware of the hazards of ineffective cleaning.

• Contaminated settings must be cleaned appropriately, according to local policies, by trained staff who are aware of the hazards of ineffective cleaning.

Laundry

• Patients’ soiled bed linen or nightwear should be treated as infected linen and placed in an inner dissolvable and an outer solid red bag.

• Patient/staff clothing contaminated with cytotoxic agents or waste from a patient receiving chemotherapy must be removed immediately. Personnel should wear appropriate clothing for dealing with a spillage. Rinse the clothing under running tap water. Squeeze dry and place in a plastic bag. Personal clothing should be taken home for laundering on the hottest wash. Handle all pre-washed laundry with gloves. If contaminated clothing is non-essential, disposal is advised

6.4 INFORMATION REGARDING CHEMOTHERAPY

Written information will be offered to all patients covering both general and specific information about SACT, side effects, preventive measures and support.


Current Macmillan Cancer Support information will be offered relating to specific drugs and regimens. Details of the 24-hour emergency contact number are provided on wallet-sized cards to all patients for patients receiving Intravenous (IV) and oral SACT. Materials are available in languages other than English through the Macmillan Information and Support centre.

Holistic Assessment In addition to a physical assessment each patient must have their holistic needs (Social, Psychological, Emotional and Spiritual) assessed prior to, during and at the end of chemotherapy treatment and appropriate action implemented. This may include referral to and liaison with other agencies and services providing supportive care. The needs of carers should also be taken into account. One-to-one holistic assessments are available with HODU practitioners. A group session called ”Demystifying chemotherapy: Planning ahead” is run in the Macmillan Centre by experienced oncology nurses on Thursday afternoons. The session can be booked through the Macmillan Centre

6.5 CONSENT FOR CHEMOTHERAPY

All patients who are to receive SACT must sign a Consent Form prior to commencing a course of treatment. Signing the consent form acknowledges that the patient has received generic written information and regimen-specific information where appropriate. In order that patients fully understand the nature of the proposed treatment, information relating to the treatment intent, risks and benefits should be given verbally and supported by the use of patient information leaflets. The information must be given initially by the medical practitioner responsible for the patient’s care, either a consultant, staff grade or specialist registrar, and will be re-enforced by an appropriately trained chemotherapy nurse. The medical practitioner or chemotherapy-trained nurse must document the information given to the patient in the patient’s healthcare record.

6.6 PRESCRIBING CHEMOTHERAPY Safe systems of work ensure that the prescription is clear, unambiguous, accurate and appropriate for that patient. Each drug should be administered by the route most appropriate for the drug formulation, the treatment regimen and the needs of the patient. See section 5 for prescriber’s responsibilities. The following information must be documented on the prescription sheet or when e-prescribing. • Patient’s demographic details. • Patient’s performance status • Patient’s height, weight and calculated surface area. • Consultant’s name (responsible for this treatment plan). • Diagnosis • Treatment intent (palliative, curative, adjuvant, neo-adjuvant etc.). • Investigations • Intended number of cycles. • Cytotoxic drug regimen/cycle number. • Drugs, dosage and route of administration. • Date, time and duration of administration. • Infusion fluid where applicable.


• Doctor’s signature/date of prescription. • The clinical review box within Aria or on all chemotherapy charts must be signed by the

clinician before the chemotherapy can be given • Confirmation that consent has been obtained

6.7 VERIFICATION PROCEDURES

Nurses must ensure that a formal checking procedure is undertaken to ensure that the correct drugs and correct doses are given to the correct patient on each occasion in accordance with PHT Management of Medicines policy. All chemotherapy checks should include two registered nurses of which at least one should be on the chemotherapy register • Identity band • MRSA screening • Check: Patient’s full name and date of birth, both verbally with the patient using active checks

(“please confirm your name and date of birth”) and against patient identify band for all patients.

• Known allergy history. • Patient’s identification on prescription chart is the same as on all labeled drugs. • Drugs:

o Dose of drug o Administration route and duration o Expiry date o Check for precipitation or discoloration o Dilution i.e. volumes

• Cycle number. • Results of clinical tests i.e. Full Blood Count (FBC)/Urea and Electrolytes (U&E). • Confirm with patient date of most recent test • Supporting medication is prescribed, i.e. anti emetics, medication to take home (TTO). • Hydration if required. • Regimen and individual drug identification within that regimen. • The review clinician box is signed by the clinician. • Nurse signs clinical review for day 8 and 15 as per regimen charts • Any doubt or question will result in administration being withheld until discussed/checked with

the clinician and/or oncology pharmacist • Patients understanding and consent

6.8 ADMINISTRATION

Routes of administration Cytotoxic drugs can be administered via a variety of routes. Regardless of the route used there are certain pre-administration principles which the nurse should apply. The nurse should remember that the administration of medicine is a collaborative process that involves the patient, nurse, doctor and pharmacist. (Doughty and Lister 2004) The nurse must identify and remedy any knowledge or practice deficit (NMC 2002) Oral administration procedures

Appropriate gloves should be worn when handling containers and SACT. The “no touch” principle applies to handling oral preparations of cytotoxic drugs. Whenever possible, tablets should be used in preference to solutions and should be blister or foil packed so that a “no touch” opening technique may be used. In pharmacy departments, only designated counting triangles must be used.


If liquids need to be used advice from the pharmacy department should be sought about safe handling. Labels on oral preparations should warn all users of the hazards of touching tablets or liquids directly. Crushing tablets, opening capsules or chewing is not recommended.

Do not crush tablets. If the patient cannot swallow the tablet, seek advice from pharmacy regarding the possible use of elixir or soluble forms. Disposable medicine cups/spoons used for administration of oral SACT must be disposed of in a designated cytotoxic waste container. Please also refer to any individual specific drug protocols.

Intravenous administration procedures

This is the most commonly used route of administration via a peripheral or central vein. It enables:

• Rapid and reliable delivery of cytotoxic drug – into the bloodstream to the tumour site.

• Rapid dilution of a drug to reduce local irritation and the risk of tissue damage.

Cytotoxic drugs must not be removed from their packaging before all checks on patient identification and prescription are complete. On completion of these checks, place patient identity labels which are found on the outside packaging onto the syringes or bags which are to be administered. This will ensure safe administration of the correct drug to the correct patient.

Appropriate Personnel Protection should be worn when handling containers and chemotherapy i.e. gloves and aprons. Drugs used to treat anaphylaxis should be available and practitioners familiar with anaphylaxis treatment guidelines, including the drugs used to treat anaphylaxis.

Venous Access

The Vascular Access Device Vascular access devices for SACT administration must be selected and used by a practitioner who has been trained, completes periodic updates and has been assessed in practice to use them appropriately.

Factors for consideration may be summarised as follows

Therapy related factors Device Related Factors Patient Related Factors

Type of therapy Length of therapy

Device associated with the least complications. Potential complications. Maintenance/care. Latest technology. Cost of placement and aftercare. Technical expertise of staff to properly use device. Preference of the nurses caring for the device. General experience of centre.

Suitability/availability of patient veins. Self-care ability. Dexterity of patient. Patient preference. Co-morbid conditions. Patients’ lifestyle (occupational and recreational activities).


Cytotoxic drugs should not be administered if there is any doubt regarding the safety of the venous access device. Due consideration should be given to the site, position, patency, integrity, visibility and need for site care of the chosen device.

Peripheral Venous Access Newly placed small gauge Teflon or silicone cannulae are recommended for the administration of cytotoxic therapy. Small gauge cannulae (22 or 24) permit an increased blood flow round the cannula and therefore haemodilution of the drug, which reduces the risk of chemical phlebitis.

Insertion site • Large veins of the forearm. Areas to avoid • Antecubital fossa. • Lower limbs. • Inflamed or sclerosed veins. • Sites distal to recent cannulation. • Any limb with compromised circulation should also be avoided. • Any limb with suspected or potential lymphoedema i.e. post axillary clearance in breast

cancer patients

Central Venous Catheters Central venous access i.e. skin tunneled or non-skin tunneled catheters or Peripherally Inserted Central Catheters (PICCs) may be used when: • The patient has poor peripheral venous access. • Needle phobia. • The patient is to undergo intensive chemotherapy. • Continuous infusional chemotherapy. • Patient choice. • Drugs to be administered are irritants to the vein and may lead to increased risk of

extravasation and chemical phlebitis. Full guidelines on Peripheral Cannulation (Adults), and Central Venous Access are available on the Intranet. Cytotoxic drugs must not be given if there is any doubt about the patency and integrity of the venous access. The patency of the cannula or central line should be checked by aspirating and flushing with 10mls of appropriate / compatible IV infusion fluid.

Vesicant drugs and Non-vesicant drugs Vesicant drugs have the potential to cause severe tissue damage and necrosis if inadvertently administered into the subcutaneous tissue. The administering nurse must be aware of the agents that are capable of causing tissue necrosis which are documented in the Cytotoxic Extravasation treatment guidelines and drug protocols. Vesicant drugs should be given first out of a group of agents as • vascular integrity decreases over time. • the vein is most stable and least irritated at the start of treatment. • initial assessment of vein patency is the most accurate. • the patient’s awareness of changes is more accurate.

Peripheral Vein Administration – Bolus drugs Prior to the administration of SACT it is vital to check the patients blood results.

• Assess the patient’s peripheral venous access


• A small cannula should be inserted into a recommended site, preferably the forearm, avoiding the ante cubital fossa.

• Patency should be checked at the start of administration by achieving a blood return and then flushing with 10mls of 0.9% sodium chloride to ensure there is no resistance, swelling or pain.

• All bolus vesicant agents should be injected / administered slowly via a needle-less system, whilst the infusion is flowing rapidly and freely under gravity only (No infusion pump should be used when administering group 5 vesicant bolus’)

• Vesicant agents must never be administered as an infusion directly into a peripheral vein via a cannula. These drugs should always be diluted with concurrently running compatible fluids.

• During any IV infusion the cannula should be checked regularly for signs of inflammation and / or infection.

• If the IV infusion is not flowing freely at a fast rate, the chemotherapy must be stopped immediately and the vein patency rechecked.

• If more than one non-vesicant drug is to be administered by bolus injection or infusion a flush of a compatible IV fluid must be given in between drugs to prevent any interaction.

• At the end of the SACT administration the giving set must be flushed through with 50mls of 0.9% sodium chloride to clear the line and the cannula.

• All used equipment must be placed in appropriate labeled designated cytotoxic containers.

• Complete appropriate documentation i.e. sign prescription chart and document in nursing notes.

Central vein administration Using aseptic technique

• Patency should be checked at the start of administration by achieving a blood return and then flushing with 10mls 0.9% sodium chloride to ensure there is no resistance, swelling or pain

• SACT agents may be infused / injected directly via a central line using a needle-free system

• Care should be taken when injecting cytotoxic chemotherapy via a central line as the patient may experience unpleasant sensations such as dizziness, palpitations if some drugs are administered too quickly.

• At the end of the infusion / injection the line must be adequately flushed through with 50mls 0.9% sodium chloride.

• All used equipment must be placed in a designated cytotoxic waste container. • Complete appropriate documentation i.e. sign prescription chart and document in nursing

notes.

Recommended practice for administration of continuo us infusional cytotoxic chemotherapy via a Baxter pump

Ambulatory chemotherapy has enabled cancer patients to receive intravenous chemotherapy at home. It has the reported advantages of improving treatment outcomes and enhancing psychological benefit to the patient. Ambulatory chemotherapy must be administered via a central venous catheter.

• Using an aseptic technique, patency should be checked at the start of administration by achieving a blood return and then flushing 10mls 0.9% sodium chloride to ensure there is no resistance, swelling or pain

• Remove Luer cap at the end of Baxter pump set and wait for fluid to show. Place the luer cap in a bag and ask the patient to keep it safe in case of disconnection when the cap can be reused to prevent the leakage of cytotoxic agent.

• Once fluid is visible attach end of pump to central line. • Dress line according to Central Venous Catheters: Care and management policy


• Complete appropriate documentation i.e. sign prescription chart and document in nursing notes.

• Arrange for disconnection and flushing of the line and removal of the pump. During week days this will be in HODU. For pumps that will be disconnected at the weekend inform the ward bleep holder (Bleep 0070)

• Provide 24-hour on-call telephone numbers. Additional support for community nurses should be offered i.e. training in pump and line management.

Subcutaneous Chemotherapy and Intramuscular Chemoth erapy

• Ensure patient is comfortable and has any specific information required. • Inspect sealed bag before opening to ensure there is no spillage within the bag. Open the

bag directly onto the injection tray. • Choose a suitable site for the injection and prepare the skin as per policy. • Carefully remove the connector top from the syringe and attach a 25 gauge needle

(orange). Ensure needles for administration are secure taking great care to minimize risk of spillage onto the skin.

• Using a pinch technique for subcutaneous chemotherapy administer the injection using a 90-degree angle. Aspiration is not required prior to the injection.

• For intramuscular chemotherapy administer injection using Z track technique. The Z track technique involves displacing the skin and the subcutaneous layer in relation to the underlying muscle so that the needle track is sealed off before the needle is withdrawn therefore minimizing reflux.

• Remove the syringe and needle, covering the site with low lint gauze ensuring there is no leakage from the site.

• All used equipment must be placed in appropriate labeled designated cytotoxic containers.

• If further injections are required, rotate the site of administration.

Extravasation Extravasation of a vesicant or irritant drug may have serious implications for the patient. Intravenous chemotherapy administration procedures and techniques are designed to prevent and minimise the occurrence of extravasation incidents. Early detection and prompt appropriate action is required to prevent damage which may in extreme cases result in necrosis and functional loss of the tissue or limb involved. For specific guidance on the management of suspected extravasation see PHT Drug Therapy Guideline “cytotoxic extravasation treatment” available via the intranet. Guidelines and extravasation kits for the treatment of cytotoxic extravasation are available in all designated areas.

6.9 WORKLOAD - POTENTIALLY UNSAFE CHEMOTHERAPY WORK LOADS

The term “chemotherapy workload” refers to the administration of systemic, intravenous, intramuscular, oral, subcutaneous or intrathecal chemotherapy in an in-patient, out-patient or day case setting. The decision that chemotherapy workload has reached an unsafe level can be made by:-

• The ward manager in charge of HODU • The Sister in charge of F5/F6/F7 • The Head of Chemotherapy Service • The Lead Haematology-Oncology Pharmacist

The variables that influence whether or not it is safe to administer chemotherapy may include:

• Staffing levels – nursing • Staffing levels – medical


• Staffing levels – pharmacy • Staffing levels – other • Availability of beds (in-patient / day case) • Availability of chairs (day case) • Availability of central pharmacy cytotoxic reconstitution service • Acuity of patient/s • Inclement weather conditions • Major Incident (Internal / External)

It should be noted that this may not be an exhaustive list.

In the event that one or more of these variables are such that the staff detailed above consider chemotherapy workload has reached an unsafe level, they may take the following action.

• Assess whether local action can be taken to resolve the situation and make it safe (e.g. postponing patient admissions, redistributing staff) and take action accordingly.

• If further action is required the staff member should escalate the situation for further discussion and for the development of an appropriate and safe action plan, which may include existing resources from elsewhere or in extreme circumstances sending the patient to another NHS Trust.

o Bleep Holder F5/F6/F7 o Sister in charge of HODU o Sister in charge of F5/F6/F7 o Matron for cancer services o Cancer Services Strategic Lead Nurse o Head of chemotherapy service o Lead Haematology / Oncology Pharmacist o Manager of Railway Triangle (licensed cytotoxic unit) o General Manager, Cancer Services o Business Manager, Regional Cancer Centre

It is the responsibility of the relevant nurse in charge of the affected area to complete a Safety Learning Event incident form relating to the period of unsafe chemotherapy workload which should be investigated according to the Trust’s governance policy. Any patient cancellations or deferrals should be recorded in the patient’s medical record.

7. TRAINING REQUIREMENTS

SACT should be given only by nursing staff who are experienced and competent in the administration and care of patients receiving cytotoxic drugs and the management of possible side effects, or staff under the supervision of such an individual. Staff administering SACT have a yearly competency assessment completed by the Clinical Educator in chemotherapy and attend training at either network level or a recognized chemotherapy course at university. All aspects of this policy will be included in audits relevant to each area of practice; these will be discussed at the Chemotherapy Governance Group. The clinical educator keeps a register of staff competency and staff deemed competent to be included on the trust chemotherapy register which is signed off annually by the lead nurse and clinical director. Training of all medical, nursing, pharmacy, facilities management and any other staff who handle cytotoxic drugs or cytotoxic waste are essential. Such staff should understand the potential hazards associated with cytotoxic drugs and be familiar with relevant procedures, i.e. management of spillage, disposal and treatment of extravasation.

Medical staff


Medical staff who are involved in the prescribing of cytotoxic drugs should be familiar with: -

• The Safe Prescribing Handling and Administration of Cytotoxic drugs for Adults.

• PHT Intrathecal Policy and National Guidance

• Network Guidelines. With the exception of medical staff on the intrathecal register medical staff do not administer chemotherapy.

All medical staff below the level of consultant and permanent staff grade doctors in the haematology-oncology department who involved in the assessment and prescription of chemotherapy should be formally assessed as competent. (See Appendix 4).

8. REFERENCES AND ASSOCIATED DOCUMENTATION Internal

1. Disposal of sharps – Waste Handling Policy 2. Safe sharps handling – Needlestick and sharps injury and contamination policy 3. Standard Infection Control Precautions - Infection Control Standard Precautions Policy 4. Aseptic Technique – Aseptic Technique Policy 5. Hand Hygiene Policy – Hand Hygiene Policy

External 1. Achieving World Class Cancer Outcomes. A strategy for England 2015-2020. Independent

Cancer Taskforce 2. Safe Handling of Cytotoxic drugs in the workplace COSHH Available at

http://www.hse.gov.uk/healthservices/safe-use-cytotoxic-drugs.htm 3. The code in full Nursing and Midwifery Council.mht 4. A Strategic Vision for Cancer. Wessex Strategic clinical Network. 5. Gilani S, Giridharan S (2014) Is it safe for pregnant health-care workers to handle cytotoxic

drugs? A review of the literature and recommendations. Available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3990661/ accessed online 6/8/2019

9. EQUALITY IMPACT STATEMENT Portsmouth Hospitals NHS Trust is committed to ensuring that, as far as is reasonably practicable, the way we provide services to the public and the way we treat our staff reflects their individual needs and does not discriminate against individuals or groups on any grounds. This policy has been assessed accordingly Our values are the core of what Portsmouth Hospitals NHS Trust is and what we cherish. They are beliefs that manifest in the behaviours our employees display in the workplace.


Our Values were developed after listening to our staff. They bring the Trust closer to its vision to be the best hospital, providing the best care by the best people and ensure that our patients are at the centre of all we do. We are committed to promoting a culture founded on these values which form the ‘heart’ of our Trust: Respect and dignity Quality of care Working together Efficiency This policy should be read and implemented with the Trust Values in mind at all times.

Cytotoxic Drugs for Adult Patients in Oncology and Haematology Version: 8 Issue Date: 25 April 2017 Review Date: 24 April 2019 (unless requirements change) of 41

10. MONITORING COMPLIANCE WITH PROCEDURAL DOCUMENTS

This document will be monitored to ensure it is effective and to assurance compliance.

Minimum requirement to be

monitored

Lead Tool Frequency of Report of Compliance

Reporting arrangements Lead(s) for acting on Recommendations

Datix involving chemotherapy

handling or administration to be

reviewed

Dr S Ellis and Dr

Caroline Chau

Catrin Watkinson

Audit Annual Policy audit report to:

• Chemotherapy governance group

Chair of chemotherapy governance group

Strategic Lead Nurse for Cancer

Cytotoxic Drugs for Adult Patients in Oncology and Haematology Version: 8 Issue Date: 25 April 2017 Review Date: 24 April 2019 (unless requirements change) of 41

APPENDIX 1:

RESPONSIBILITIES: HEAD OF CHEMOTHERAPY SERVICE

• Provision of suitable and appropriate equipment for administration of SACT.

• Co-ordination of specified chemotherapy regimens within the network.

• Supervision of SACT prescribing by clinicians and pharmacists.

• Administration of SACT by appropriately trained staff

• Use of guidelines for the prevention and treatment of side effects and complications of chemotherapy.

• Minimising delays in starting treatments.

• Clear and comprehensive documentation of SACT delivery.

• Chair of the Chemotherapy Governance Group

• Represent Portsmouth in the Wessex SCN chemotherapy meetings

• Work to promote familiarity of non-specialist services (Emergency Department, Critical Care

Unit, General Practice, Ambulatory Medical Unit, Renal Unit etc.) with chemotherapy and other SACT agents, such as small molecule inhibitors and immunotherapy related toxicities and other new SACT agents as they emerge.


APPENDIX 2: RESPONSIBILITIES OF THE LEAD CHEMOTHERAPY NURSE FOR THE PORTSMOUTH HOSPITALS NHS TRUST’S CLINICAL CHEMOTHERAPY SERVICE (ADULT)

The Lead Chemotherapy Nurse will:

• Work clinically directly with patients receiving chemotherapy as agreed in local job plan.

• Work with multidisciplinary colleagues and the Chemotherapy Governance Group to identify issues influencing the safe delivery of cancer chemotherapy.

• Lead the nursing service to effect changes that will enhance the delivery of cancer

chemotherapy in the locality according to national and network guidelines and best practice.

• Work with colleagues within the trust and within the Wessex SCN to ensure that an effective training programme is in place for all staff involved in the administration of cancer chemotherapy.

• Maintain an up-to-date register of PHT nursing staff authorised as competent to administer

cancer chemotherapy unsupervised.

• Work in conjunction with the Trust’s Intrathecal Lead and Intrathecal Training and Education Lead to ensure training and competency assessment is in place for nurses and an Intrathecal Chemotherapy register is maintained in accordance with national guidance and local policy.

• Assist in the development of relevant local guidelines and policies.

• Work closely with the Head of the Clinical Chemotherapy Service and as part of the

Chemotherapy Governance Group to ensure the development of a chemotherapy service that is patient focused and responsive to changing needs.

• Collaborate with colleagues to ensure patients have access to an appropriately staffed 24

hour, seven days a week telephone advice service on the side effects and complications of chemotherapy treatment and how to obtain help and treatment for them, via the Acute Oncology Service based on F7 ward.

• Ensure the HEAT training (neutropenic sepsis tool) is rolled out amongst staff at PHT,

delivered by the Acute Oncology team.

• Ensure that PHT is represented at the Wessex SCN Chemotherapy Group and the Chemotherapy Nurses Sub Group


APPENDIX 3: RESPONSIBILITIES: LEAD HAEMATOLOGY /ONCOLOGY PHARM ACIST The provision of clinical pharmacy services and pharmaceutical advice to Oncology and Haematology departments.

• To ensure both inpatients and outpatients receiving cytotoxic chemotherapy receive optimal pharmaceutical care and monitoring.

• To advise staff and the chemotherapy users group on the safe prescribing, dispensing,

handling and administration of chemotherapy and the development and implementation of related policies and guidelines in line with current recommendations.

• To monitor use of chemotherapy regimens on the Trust and be familiar with the list of agreed

regimens.

• To be the designated Trust training lead for intrathecal chemotherapy ensuring that national guidance is followed.

• To evaluate the potential costs and benefits of new chemotherapy drugs to inform and assist

directorate and divisional clinical and management team decision-making

• To lead on the setting-up, administration and management of oncology/haematology clinical trials.

• To monitor, evaluate and report on the cost of NICE-approved medicines on an individual

patient basis.

• To ensure regimen-appropriate charts are available on the intranet for each regimen used and in a timely fashion for new regimens and clinical trial regimens.

• To contribute to production of prescribing guidelines, patient care pathways, patient group

directions and chemotherapy proofreads to ensure safe use of medicines and maximise benefits to patients within available resources.


APPENDIX 4: Training and Competency Assessment for the Prescrib ing, Dispensing and Administration of Chemotherapy There are three specific groups who require training and regular assessment with regards to the safe administration of chemotherapy • Medical staff who prescribe SACT (Systemic Anti cancer Therapy) and ITC (Intrathecal

Chemotherapy) • Pharmacy staff undertaking reconstitution, checking and dispensing SACT and ITC • Nursing staff undertaking patient assessment immediately prior to a cycle of SACT and ITC and

also the safe administration of SACT ITC Training and Competency assessment policy is covered in the Trust ITC policy. This policy is only applicable to SACT prescribed, dispensed and administered in adult patients with malignancy. Medical Team Consultant Haemato-oncologists are considered competent to assess patients and initiate courses of SACT. These clinicians can be supported by trainees once they have been assessed as competent and are recorded on the chemotherapy register as competent to prescribe chemotherapy. Junior medical staff below the level of ST3 are not allowed to prescribe or administer chemotherapy. However, they are encouraged to observe the procedure in order to gain a better understanding of what is involved. All health care professionals other than consultants and permanent staff grade doctors in the haematology-oncology department who are involved in the assessment and prescription of SACT should be formally assessed as competent before being added to the register. Oncology SpR/ST3 and above: The Wessex Deanery Specialist Training committee has recently approved a structured 5 level competency assessment tool to assess and document the competency for the health care professionals involved in the prescription of SACT. Portsmouth CCS has agreed to use the tool for the oncology SpR/ST3 and above. During their induction, the trainee should undergo the competency assessment with their educational or clinical supervisors to document the level of competency before entering their names into the chemotherapy register. Ideally progress needs to be monitored throughout training through regular interval assessments as necessary (depending upon the level of competency identified during the initial assessment and the length of the training in Portsmouth). Haematology SpR/ST3 and above: Criteria (1) All Haematology trainees must read and be aware of the PHT Cytotoxic administration policy. They will be given a copy of this at induction. Criteria 2 (a) For 1st year trainees - Haematology Trainees are required to perform a MiniCEX around prescribing competency in Year 1 Haematology StR Curriculum. Once it is done they must meet criteria 3. Criteria 2 (b)


Post year 1 - Pre FRCPath part 1 pass they must provide evidence of this miniCEX in their educational portfolio and perform two prescriptions with a clinical or educational supervisor. Criteria 2 (c) Haematology StR (or SpR) with FRCP part 1 - to prescribe at least first prescription under supervision, prescription to be countersigned. Criteria (3) If relevant part of Criteria (2) met - the Educational Supervisor will sign off the approval for Chemotherapy prescriptions appendix of the induction sheet given to the Trainee when they started by Dr R Corser as part of their induction. A copy of this will be sent to the Chair of the Chemotherapy Governance Group Criteria (4) All trainees -Specimen signature must be supplied to Pharmacy with Countersignature by Educational Supervisor. Pharmacy Senior haemato-oncology pharmacists assess the competency of all pharmacy staff and technicians for checking, reconstitution and dispensing of SACT. Records of training and competence are kept in the aseptic suite and the names are recorded on a register also documented within the Policy for Administration of Chemotherapy. The head of the service has overall responsibility for ensuring competency of all staff who check, reconstitute or dispense chemotherapy although the haemato-oncology pharmacist undertakes day-to-day responsibility and maintains the training records. Nursing Staff All new members of nursing staff who join the HODU and inpatient wards follow an induction process to understand the service and enable them to function efficiently and safely at their level of knowledge and experience. The Wessex Cancer Network has a training course which assists in the development of trained nurses who are working with patients receiving chemotherapy. Once the ward manager is satisfied that a registered nurse is ready to administer chemotherapy, and the nurse is prepared to undertake the training, an application is made to the Network for the next available training dates. Whilst they are undergoing their training they have full supervision when administering chemotherapy and a dedicated mentor for support with any written work. Once they have completed their open learning package they forward their work to the Lead Chemotherapy Nurse for marking. There is an agreed list of assessors of competence within the Policy for Administration of Chemotherapy and only nurses named on this register are able to assess competence in administering chemotherapy at PHT. This list has been agreed with the chemotherapy head of service and will include all bands of nurses who have successfully completed the recognised network training. The band 7 clinical educator/ lead chemotherapy nurse holds the training records of all nurses working in the day unit and on the wards. Annual competency assessment for IV chemotherapy is managed by the chemotherapy lead nurse, working closely with pharmacy, the clinical chemotherapy learning facilitator and the ward manager if any specific training needs are highlighted. Competence also requires reassessment if there has been a prolonged period of absence (e.g. maternity leave). Competencies for nurses include:- Cannulation • Accessing central venous access devices


• Holistic assessment • Good understanding of cytotoxic drugs and targeted therapies including • Department of Health circulars (e.g. specific vinca alkaloid policy ) • Good communication skills in delivery of information to patients • Good understanding of blood results so that chemotherapy can be delivered safely • Drug calculations • Management of side effects • When to defer treatments or withhold a dose/drug • Management of oncology/chemotherapy emergencies (e.g. extravasation) • Managing general medical emergencies The head of service has overall responsibility for ensuring competency of all staff who administer chemotherapy although the chemotherapy lead nurse undertakes day-to-day responsibility and maintains the training records. Criteria for acting as an Assessor of competence fo r SACT: Portsmouth Clinical Chemotherapy Service (CCS) complies with the Wessex Network criteria for acting as an assessor of competence for systemic chemotherapy. Medical and Clinical Oncologists and Haematologists

An assessor of competence should meet the following criteria:

• Be a consultant haematologist or oncologist • Undertake regular continuing professional development

Documentation approved by the Royal Colleges must be used to evidence the competence of trainees (SpR/ST3 and above). (In development) Consultants should use the competencies defined for each of the four levels of practice to assess trainee competence, see below:

• Review of patient to receive systemic anti-cancer therapy (SACT) and authorisation of the next cycle to proceed

• Ability to prescribe SACT, within local guidelines, or to continue a planned course of treatment but not initiate the first course of treatment

• Ability to initiate SACT for patients with a range of malignancies, whilst prescribing within local guidelines

• Ability to initiate all appropriate SACT for a tumour specific area of clinical practice. Ability to participate in the evaluation of relevant therapies within clinical trials and therefore have a detailed knowledge of the regulatory framework defined for clinical research

Pharmacy

Pharmacists and pharmacy technicians who assess competency must be registered with the General Pharmaceutical Council (GPhC). Pharmacists and Technicians must complete the local Trust’s training and assessment programme or equivalent. They must undertake continuing professional development in accordance with the requirements of the GPhC and must have no areas of concern with their practice e.g. acceptable error rates as defined by each local acute trust. Any pharmacists or technicians involved with clinical trials must undertake Good Clinical Practice (GCP) training and be aware of Investigation Medicinal Products (IMP) handling and recording.


Pharmacy activities can be grouped into three distinct but overlapping and complimentary areas. Each activity is not distinct to the area in which it is grouped. For example clinical screening of prescriptions may occur on in-patient wards, the dispensary or aseptic unit. It should be noted that individuals may specialise or work in one or more of these areas. As such it may be impossible to spend 50% of their time working in the field of oncology and must have been deemed competent in the areas for which they are acting as assessors. Assessing competence for Clinical competencies include activities such as:

• Screening of both in-patient and out-patient chemotherapy and supportive treatments in accordance with local procedures or the British Oncology Pharmacy Association standards.

• Advising other staff and patients in relation to chemotherapy and supportive treatments Assessing competence for dispensary includes:

• Labelling, dispensing and checking (final release) of prescriptions for oral chemotherapy and supportive treatments for cancer patients

• Labelling, dispensing and checking (final release) of prescriptions for non-oral chemotherapy and supportive treatments for cancer patients where these are commercially available products

• Safe storage and handling of chemotherapy Assessing competence for aseptic includes:

• Good manufacturing practice • Development of worksheets and standard labels • Completion of the necessary documentation prior to dispensing an aseptic product e.g. batch

sheets, labels etc. • Clean room behaviour e.g. procedures for entering aseptic rooms, cleaning of rooms and

cabinets • Environmental monitoring requirements for aseptic areas • Aseptic preparation of chemotherapy • Labelling of aseptic products • Final release of aseptic products including labelling, dispensing and checking (final release) of

prescriptions for oral chemotherapy and supportive treatments for cancer patients • Final release of aseptic products including labelling, dispensing and checking (final release) of

prescriptions for non-oral chemotherapy and supportive treatments for cancer patients where these are commercially available products

• Safe storage and handling of chemotherapy • Safe transportation of chemotherapy • Spillage procedures for chemotherapy

Nursing staff Nurses working within the Wessex Cancer Network, who have not previously undertaken a recognised chemotherapy education programme e.g., ENB-N59, are expected to undertake or be working towards a network recognised chemotherapy training programme including chemotherapy practice competencies within 6- 12 months of commencing post. Chemotherapy nurses who continue to work in the field of chemotherapy should have their clinical knowledge and skills peer reviewed annually against the network recognised skills for health competencies as part of the local appraisal process. Use an annual chemo update


Only staff who have demonstrated advanced practice in chemotherapy administration and assessment will be eligible to undertake the assessment of other staff. (See Training) They must:

• Have been identified through appraisal or annual peer review process as being competent to assess. This review process will be monitored by the Trust Lead Chemotherapy Nurse.

• Undertaken an accredited course in chemotherapy at HEI academic level 6 (degree level module) or equivalent.

• Have undertaken an accredited course in teaching and/or assessing in clinical practice or have covered this in pre-registration training.

• Regularly undertake administration of chemotherapy as part of their role. • The particular competencies for which they are deemed capable as an assessor include:

Assessment of patients prior to chemotherapy, administration of chemotherapy and all aspects of the care pathway, pre-during and post administration.


PRESCRIPTION OF SYSTEMIC ANTI-CANCER THERAPY: COMPE TENCY ASSESSMENT

All Health Care Professionals (HCPs) involved in the assessment and prescription of systemic anti-cancer therapy (SACT) should be formally assessed as competent. The following document should serve as a record of assessment of competency. Competencies should be signed off by the HCPs Supervisor (e.g. named Consultant, Clinical and / or Educational Supervisor). For Medical Trainees, where possible, competencies should be assessed using validated assessment tools (e.g. DOPS, Mini-CEX or CbDs). Oncology Pharmacy should hold a summary record of assessment for all SACT prescribers. HCPs may undertake duties relating to a level of competence above a level at which they have demonstrated competence, but only under the appropriate supervision / countersignature of a suitably competent person which will usually be the patient’s named Consultant Oncologist. Only clinicians performing duties at level 5 do not require supervision.

RECORD OF ASSESSMENT FOR PRESCRIBERS OF SACT Name (please print): ………………………………………………………………………………………………….. Position:-…………………………………………………………………………………………………………………….. Usual signature: ………………………………………………………………………………………………………… Start date:……………………………………………………………………………………………………………….. Level 1 A level 1 person is able to undertake a review of a patient receiving systemic therapy and can authorise the next cycle of treatment to proceed. This professional could be medically qualified or an appropriately qualified chemotherapy nurse, oncology pharmacist or a professional allied to medicine. It is estimated that suitable training would take 3 months within the Specialist Training grade. During this period, medically qualified trainees will require the countersignature of a more senior qualified person on all prescriptions. Knowledge Assessment

LEVEL 1 COMPETENCY DATE ACHIEVED

SUPERVISOR SIGNATURE

Ability to authorise treatment to proceed following assessment of the patient and relevant laboratory investigations.

Ability to review a prescription for systemic therapy and accurately identify errors or omissions.

To demonstrate knowledge and understanding of the methods for calculating the correct dose of medication for administration including those based on body surface area, pharmacokinetic and


pharmacodynamic principles. Ability to define the scientific basis of causation of nausea and vomiting and ability to identify the likely mechanism of emesis in patient receiving systemic therapy.

Ability to determine the antiemetic requirements of patients receiving systemic therapy.

Ability to define the principles for dose delay or dose reduction of systemic therapies, based upon haematological toxicity.

ALL LEVEL 1 COMPETENCIES ACHIEVED

#1 prescriptions require countersignature Prescriptions from #2 onwards without countersignature.

GMP Level 2 A level 2 person is able to prescribe systemic therapy, within local guidelines, or to continue a planned course of treatment but not initiate the first cycle of treatment. This professional is likely to be medically qualified or a senior non-medical prescriber. It is estimated that suitable training would be completed within the first 3-4 months within the Specialist Training grade. Knowledge Assessment



To define the range of systemic therapies utilised in the treatment of patients with cancer and define the likely adverse effects of the agents in more common usage within a clinical service.

Ability to prescribe and order systemic therapies following assessment of the patient and relevant laboratory investigations, using appropriate systems defined by the local authorities.

Ability to accurately prescribe systemic therapies using various methods for calculating the correct dose of medication for administration including those based on body surface area, pharmacokinetic and pharmacodynamic principles.

To define the scientific basis and parameters for dose modifications to systemic therapy in the light of clinical data relating to the liver, renal, haematological and other organ systems.

Ability to institute appropriate modifications in the prescription of systemic therapy in the light of clinical data that will relate to dose modification parameters relating to organ function.

Ability to perform a thorough assessment of toxicity and record the clinical information using defined systems such as the Common Toxicity Criteria.

Ability to prescribe antiemetic medications appropriate to the chosen therapy and modified following review of the patients’ situation and symptoms following previous treatments.

Ability to define and initiate appropriately the pharmacological and non-pharmacological supportive measures that may be required by patients receiving systemic therapy, including growth factors and


antibiotics. Ability to define the indications for and adverse reactions associated with the use of blood products and ability to initiate appropriate prescription following assessment of patients’ requirements. Prescription of blood products is at present not permitted by non-medical prescribers.

Ability to obtain informed consent for procedures and initiation of treatments.

Ability to request assistance and advice when a situation requires the involvement of a more senior colleague.

Ability to determine the appropriateness of continuing treatment, particularly in patients with poor performance status or significant comorbid conditions.

Ability to assess objective tumour responses and toxicity and make a balanced judgement about continuing.

ALL LEVEL 2 COMPETEN CIES ACHIEVED #1 prescriptions require countersignature.

Prescriptions from #2 onwards without countersignature

Level 3 A person at level 3 is able to initiate systemic therapy for patients with a range of malignancies, whilst prescribing within local guidelines. This professional will be medically qualified. It is estimated that suitable training would be completed within the first 6 months within the Specialist Training grade. Methods



To define the scientific mechanism of action of the systemic therapies used in the management cancer patients.

Ability to initiate systemic therapy for common cancers following detailed assessment of a patient and considering the decisions made during a multidisciplinary team meeting.

Ability to modify the dosage of systemic therapy based on pharmacokinetic and pharmacodynamic information relating to a patient.

Ability to appropriately request assistance or advice when a situation requires the involvement of a more senior colleague.

Demonstrate a knowledge and understanding of the structure of network agreed regimens and what processes are required to agree use of non-approved regimens, either on a one off basis, or more frequently.

ALL LEVEL 3 COMPET ENCIES ACHIEVED All prescriptions without countersignature.

Treatment plan to be agreed with supervising consultant.

Level 4


A level 4 person is able to initiate all appropriate systemic therapies for a tumour specific area of clinical practice. They will also be able to participate in the evaluation of relevant therapies within clinical trials and therefore have a detailed knowledge of the regulatory framework defined for clinical research. This professional will be medically qualified. It is estimated that suitable training would be completed within the 6 months requirement for each mandatory clinical module within the Specialist Training grade. Therefore a level 4 competence is a requirement to complete training in the clinical modules required for CCT. GMP



Ability to critically evaluate and interpret published evidence relating to the investigation of a new therapeutic agent.

Authorise treatment to proceed following assessment of the patient and relevant laboratory investigations.

Trainees at this level are encouraged to become investigators on clinical trials within the tumour specific area.

Ability to define the regulatory framework for the development of new therapies used in the treatment of patients with cancer.

Ability to request assistance and advice when a situation requires the involvement of a more senior colleague.

ALL LEVEL 4 COMPETEN CIES ACHIEVED All prescriptions without countersignature.

Treatment plan to be agreed with supervising consultant.

Level 5 A level 5 person is able to introduce a new therapy into a clinical department. This may be following a critical review of published evidence or as a clinical trial to evaluate a new therapy. This person can also devise a new treatment for a condition and propose appropriate methods for critical evaluation and determination of the cost-effectiveness. This professional will be medically qualified and likely to be a Consultant Oncologist. The demonstration of this level of competence will be by the award of Certificate of Completion of Training (CCT) in Oncology. Suitable training will take 48 months in an approved training programme within the Specialist Training grade. A level 5 clinician will have demonstrated competence at level 4 in all clinical modules required for CCT in Oncology.



Ability to define strategies to introduce a new therapy within a clinical department.

Ability to critically review the evidence of benefit for a new therapy and to advise the local authorities regarding the cost-effectiveness and likely benefits to patients treated within the clinical service

Ability to identify the training needs of all health care professionals involved in the delivery of a systemic therapy service, required to introduce a new therapy into a clinical service.

Ability to customise a treatment to an individual patient, based on all investigative information, when local guidelines are not applicable to the clinical situation, or when there is a lack of clinical evidence for a


particular situation (such as a rare tumour for which randomised controlled trial data is not available). Ability to lead a clinical trial as a local Principal Investigator.

Ability to be an educational supervisor and oversee those training in chemotherapy competencies.

ALL LEVEL 5 COMPETENCIES ACHIEVED

Consultant level prescriber.

Knowledge Assessment ONCOLOGY PHARMCY SUMMARY RECORD OF ASSESSMENT FOR PRESCRIBERS OF SACT

Name (please print): ………………………………………………………………………………………………….. Position:-…………………………………………………………………………………………………………………….. Usual signature: ………………………………………………………………………………………………………… Start date:…………………………………………………………………………………………………………..

AGREED COMPETENCY LEVEL

DATE ACHIEVED SUPERVISOR SIGNATURE

Level 0 All prescriptions require countersignature.

Level 1 #1 prescriptions require countersignature. Prescriptions from #2 onwards without countersignature.

Level 2 #1 prescriptions require countersignature. Prescriptions from #2 onwards without countersignature.

Level 3 All prescriptions without countersignature. Treatment plan to be agreed with supervising consultant.

Level 4 All prescriptions without countersignature. Treatment plan to be agreed with supervising consultant.

Level 5 Consultant level prescriber.


EQUALITY IMPACT SCREENING TOOL To be completed and attached to any procedural docu ment when submitted to the

appropriate committee for consideration and approva l for service and policy changes/amendments.

Stage 1 - Screening

Title of Procedural Document : Prescribing, Handling and Administration of Cytotoxic Drugs for Adult Patients in Oncology and Haematology

Date of Assessment 08 March 2017 Responsible

Department Pharmacy

Name of person completing assessment

Catrin Watkinson Job Title Pharmacy Clinical Service Manager

Does the policy/function affect one group less or m ore favourably than another on the basis of :

Yes/No Comments

• Age No

• Disability

Learning disability; physical disability; sensory impairment and/or mental health problems e.g. dementia

No

• Ethnic Origin (including gypsies and travellers) No

• Gender reassignment No

• Pregnancy or Maternity No

• Race No

• Sex No

• Religion and Belief No

• Sexual Orientation No

If the answer to all of the above questions is NO, the EIA is complete. If YES, a full impact assessment is required: go on to stage 2, page 2

More Information can be found be following the link below

www.legislation.gov.uk/ukpga/2010/15/contents


Stage 2 – Full Impact Assessment

What is the impact Level of Impact

Mitigating Actions (what needs to be done to minimise / remove the impact)

Responsible Officer

Monitoring of Actions

The monitoring of actions to mitigate any impact will be undertaken at the appropriate level

Specialty Procedural Document: Specialty Governance Committee

Clinical Service Centre Procedural Document: Clinical Service Centre Governance Committee

Corporate Procedural Document: Relevant Corporate Committee

All actions will be further monitored as part of reporting schedule to the Equality and Diversity Committee