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The Newcastle upon Tyne Hospitals NHS Foundation Trust

Policy for the handling, segregation and disposal of cytostatic and cytotoxic waste

Version No.: 2

Effective From: 13 March 2019

Expiry Date: 13 March 2022

Date Ratified: 26 February 2019

Ratified By: Clinical Policy Group

1 Introduction Pharmaceutical waste can be divided into three broad groups: 1. Pharmaceutical Hazardous (cytotoxic and cytostatic) 2. Pharmaceutical Non-Hazardous (non-cytotoxic and non-cytostatic) 3. Not pharmaceutically active and possessing no hazardous properties (examples include saline and glucose) The only medicinal products that are automatically deemed to be hazardous are cytotoxic and cytostatic medicines. These medicines are defined as any medicinal product that has one or more of the following hazardous properties: Toxic, Carcinogenic, Mutagenic or Toxic for Reproduction. Please note that Toxic for Reproduction should not be confused with Contraindicated for Use in Pregnancy; the former is based on specific chemical risk phrases. The definition of cytotoxic and cytostatic in waste classification is much broader than the term cytotoxic used in the clinical setting as set out in Chapter 8.1 of the British National Formulary. Both non-hazardous and hazardous medicinal waste requires incineration with the latter requiring high temperature incineration. Therefore, to avoid the obvious financial and environmental burden DH guidance clearly defines the need for all healthcare associated waste to be segregated into the appropriate waste stream. Failure to comply with this Policy may render the individuals and/or the Trust liable to prosecution, which can result in substantial fines, imprisonment and adverse publicity. 2 Scope This policy applies to all members of staff, including locum/agency staff, involved in the supply, administration and disposal of medicines within the Trust.

3 Aims The aim of the policy is to ensure that all medicinal waste is segregated in accordance with DH guidance. Furthermore this policy also deals with the safe handling of cytostatic medicines that is not covered in other Trust medicines related policies or guidelines.

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4 Duties (Roles and responsibilities) 4.1 The Executive Team is accountable to the Trust Board for ensuring Trust-wide compliance with policy. 4.2 Directorate managers and heads of service are responsible to the Executive Team for ensuring policy implementation. 4.3 Managers are responsible for ensuring policy implementation and promoting awareness of this policy amongst their employees. 4.4 The Trust Waste Manager is responsible for advising on practice and periodic monitoring of compliance. 4.5 The pharmacy department are responsible for maintaining the Trust list of recognised cytostatic and cytotoxic drugs. 5 Definitions 5.1 Hazardous properties (code):

Toxic (H6): substances and preparations (including very toxic substances and preparations) that, if they are inhaled or ingested or if they penetrate the skin, may involve serious, acute or chronic health risks and even death.

Carcinogenic (H7): substances and preparations that, if they are inhaled or ingested or if they penetrate the skin, may induce cancer or increase its incidence.

Toxic for Reproduction (H10): substances and preparations that, if they are inhaled or ingested or if they penetrate the skin, may induce non-hereditary

congenital malformations or increase their incidence.

Mutagenic (H11): substances and preparations that, if they are inhaled or ingested or if they penetrate the skin, may induce hereditary genetic defects or increase their incidence.

5.2 Clinical Governance approval: This is approval from the North of Tyne Area Prescribing Committee1 or from the Chair of the Trust’s Medicines Management Committee in the case of one off formulary approvals/individual funding requests.

1 The North of Tyne APC endorses NICE Technology Appraisals, NHS Commissioning Board Clinical

Reference Group Decisions (CRGs) and previous NECDAG (pre 1st April 2013)/CRGs (post 1st April 2013) decisions in the case of cancer chemotherapeutic agents.

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6 Designation, Handling and disposal of cytostatic and cytotoxic medicines 6.1 Pharmacy procedures for the designation of medicines into cytostatic, cytotoxic or non-hazardous categories.

Following Clinical Governance approval medicines will be designated as non-hazardous, cytostatic or cytotoxic at the point at which they are added to pharmacy computer system (JAC).

Medicinal products identified as being cytostatic or cytotoxic will be tagged accordingly on JAC with the appropriate special consideration.

Medicinal products identified as being cytostatic or cytotoxic will be added to the Trust List of Recognised Cytotoxic and Cytostatic Drugs (see appendix 1) which is available on the pharmacy intranet page and waste intranet page.

Medicinal products designated as cytostatic will be given the initial main store and/or initial dispensary location of new cytostatic or new cytotoxic for cytotoxic medicines.

6.2 Pharmacy procedures for the receipt and issue of cytostatic and cytotoxic medicines in the main store(s). 6.2.1 Receipt

Upon receipt of a cytostatic or cytotoxic medicine into the main store new cytostatic location or new cytotoxic location a sound alike/look alike risk assessment will carried out by the location manager before being placed in the cytostatic or cytotoxic medicine store location.

6.2.2 Issue

Ward stock cytostatic medicines will be marked at the point of issue with a cytostatic yellow label2 and placed by nursing staff in the designated cytotoxic/cytostatic ward drug storage area (where available).

Ward stock cytotoxic medicines will be marked at the point of issue with the cytotoxic yellow label3 and placed by nursing staff in the designated cytotoxic/cytostatic ward drug storage area (where available).

2 Caution – this is a cytostatic agent - observe cytostatic handling procedures

3 Caution – this is a cytotoxic agent - observe cytotoxic handling procedures

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6.3 Pharmacy procedures for the receipt and issue of cytostatic and cytotoxic medicines in the dispensaries(s). 6.3.1 Receipt

Upon receipt of a cytostatic medicine into the dispensary new cytostatic location a sound alike/look alike risk assessment will carried out by the location manager before the stock is stored in the dispensary.

Upon receipt of a cytotoxic medicine into the dispensary new cytotoxic location a sound alike/look alike risk assessment will carried out by the location manager before the stock is moved to the dispensary cytotoxic location.

6.3.2 Issue

Ward stock cytostatic medicines will be marked at the point of issue with a cytostatic label.

Ward stock cytotoxic medicines will be marked at the point of issue with a cytotoxic yellow sticker.

Individually charged cytostatic medicines that are not given to patients (i.e. high cost tariff excluded drugs that have to be identified and then charged to the commissioners) will be marked at the point of issue with a cytostatic label.

Individually charged cytotoxic medicines that are not given to patients (i.e. high cost tariff excluded drugs that have to be identified and then charged to the commissioners) will be marked at the point of issue with a cytostatic label.

Patient identifiable cytostatic medicines (i.e. given to the patient at discharge or outpatient appointment) should not be marked with a cytostatic label.

Patient identifiable cytotoxic medicines (i.e. given to the patient at discharge or outpatient appointment) should not be marked with a cytotoxic label but should have the agreed JAC supplementary label added.

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6.4 Pharmacy procedures for the disposal of cytostatic and cytotoxic medicines

6.4.1 Disposal

For full details regarding the disposal of medicines the please refer to pharmacy policy (NuTH WD STORES 9: Management and Disposal of

Pharmaceutical Waste) and the Trust Waste Management Policy. 6.4.2 Identifying the correct waste stream for disposal of medicines

When disposing of medicines, staff in the Trust Pharmacy and Production Unit should check that the designation of the medicine by referring to the most up to date cytostatic and cytostatic medicines list.

o The must up to date list can found on the BNF and Medicines

resources tab of the intranet http://nuth-vintranet1/cms/ClinicalDirectorates/Pharmacy/BNFMedicinesResources.aspx

o Cytostatic and cytotoxic medicines should be placed in the purple waste stream.

o Non-hazardous medicines should be placed in the blue waste stream.

6.5 Responsibilities of clinical staff

6.5.1 Administration of cytostatic medicines Staff do not require specific training, as for cytotoxic medicines, to administer cytostatic medicines but should refer to the summary of product characteristics (SPC) (http://emc.medicines.org.uk/) or package insert for any additional handling instructions.

When administering injectable cytostatic drugs staff should use the following PPE: nitrile gloves, eye protection and a plastic apron.

Nitrile gloves are not required when popping out intact cytostatic capsules/tablets from blister packs.

Nitrile gloves should be worn when handling cytostatic liquids or cytostatic capsules/tablets from bulk containers.

o Note: It is recommended as good practice that staff use nitrile gloves when administering non-hazardous oral liquid medicines or when opening non-hazardous intact capsules.

Solid dosage forms of hazardous medicines should not be crushed or intact capsules should be opened without seeking advice from pharmacy.

o In event that pharmacy advise that this is appropriate PPE as above (including a mask) should be worn.

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6.5.2 Administration of cytotoxic medicines

Staff administering cytotoxic medicines should do so in a accordance with the Anticancer Medicines Policy AND Guidance on the Management of Patients receiving Cytotoxic Chemotherapy for Non Malignant Conditions

Solid dosage forms of cytotoxic medicines should not be crushed. 6.5.3 Segregation and disposal of cytostatic and cytotoxic medicines

For full details regarding the segregation and disposal of waste please refer to the Trust Waste Management Policy.

The use of the cytotoxic or cytostatic labels on issues from the Trust pharmacy and those from the Pharmacy Production Unit are intended help identify these medicines however the absence of one of these labels does not imply that the medicine is not cytotoxic or cytostatic, therefore:

o It is the responsibility of clinical staff to familiarise themselves with

the cytostatic and cytotoxic medicines in use within their area to ensure that they can be segregated from the non-hazardous medicines at the point of disposal.

o This should be done by referring to the Trust List of Recognised Cytotoxic and Cytostatic Drugs and/or through consultation with the Pharmacy or Trust Waste Manager.

Both cytotoxic and cytostatic medicines must be disposed of in the purple waste stream.

7 Training It is the responsibility of each Clinical Directorate to ensure that all relevant staff have training, as appropriate, on this policy. Specifically those clinical staff involved in the administration of cytotoxic medicines should have received training in accordance with Anticancer Medicines Policy AND Guidance on the Management of Patients receiving Cytotoxic Chemotherapy for Non Malignant Conditions. 8 Equality and diversity The 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 document has been appropriately assessed. 9 Monitoring compliance

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Compliance with this policy will be monitored as stated within the Trust Waste Management Policy.

10 Consultation and review This policy has been produced by Directorate of Pharmacy and Medicines Management and Pharmacy Production Unit in consultation with the Trust Waste Manager and Nurse Consultant NCCC.

11 Implementation (including raising awareness) The Trust Waste Manager and the main author of this policy will ensure that the all Clinical directorates are aware of this policy and liaise, as required, with the relevant individuals to ensure implementation. 12 References NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2016 https://www.cdc.gov/niosh/topics/hazdrug/ FDA pregnancy categories http://www.drugs.com/pregnancy-categories.html Summary of product characteristics (SPC) (http://emc.medicines.org.uk/) Safe Management of Healthcare Waste, Department of Health, 2011 Waste Management Policy, The Newcastle upon Tyne Hospitals NHS Foundation Trust, Version 6.1, December 2014

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Appendix 1

Recognised list of Cytostatic Medicines

The following medicines are classed as cytostatic and are required to be disposed of via the purple waste stream. Staff do not require specific training, as for cytotoxic medicines, to administer cytostatic medicines but should refer to the summary of product characteristics (SPC) (http://emc.medicines.org.uk/) or package insert for any additional handling instructions.

When administering injectable cytostatic drugs staff should use the following PPE: nitrile gloves, eye protection and a plastic apron.

Nitrile gloves are not required when popping out intact cytostatic capsules/tablets from blister packs.

o Note: It is recommended as good practice that staff use nitrile gloves when administering any liquid medicines or opening intact capsules.

Nitrile gloves should be worn when handling cytostatic capsules/tablets from bulk containers

Solid dosage forms of hazardous medicines should not be crushed or intact capsules should be opened without seeking advice from pharmacy. In event that pharmacy advise that this is appropriate PPE as above (including a mask) should be worn.

The presence of a medicine in the below list does not imply that this medicine is available for use on the North of Tyne and Gateshead Formulary or is stocked in NUTH pharmacies.

Abacavir Estradiol/drospirenone Nintedanib

Abiraterone Estradiol/nomegestrol Nivolumab

Acitretin Estradiol/Norethisterone Norelgestromin

Afatinib Estrogen-progesterone combinations

Norethisterone

Aflibercept* Estrogens, conjugated Norgestimate

Aldesleukin Estrone Oestrogens

Alectinib* Estropipate Osimertinib*

Alitretinoin Ethinylestradiol Oxytocin

Ambrisentan Ethinylestradiol/desogestrel Palbociclib*

Anastrozole Ethinylestradiol/drospirenone Pazopanib

Atezolizumab* Ethinylestradiol/etonogestrel Phenindione*

Atripla® (efavirenz/ emtricitabine/tenofovir disoproxil)

Ethinylestradiol/gestodene Pembrolizumab

Axitinib Ethinylestradiol/levonorgestrel Pentamidine

BCG - connaught Ethinylestradiol/norelgestronim Pertuzumab

BCG Tice Ethinylestradiol/norethisterone Plerixafor

BCG vaccine Ethinylestradiol/norgestimate Podophyllotoxin

Bevacizumab Etonogestrel Pomalidomide

Bexarotene Everolimus Ponatinib

Bicalutamide Exemestane Raloxifene

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Bosentan Finasteride Ranubizumab

Bosutinib Fingolimod Regorafenib*

Brincidofovir* Flutamide Ribavirin

Buserelin Foscarnet Ribociclib*

Cabozantinib Fulvestrant Riociguat

Ceritinib Ganciclovir Ruxolitinib

Cetrorelix Gefitinib Sirolimus

Cetuximab Gemeprost Sorafenib

Chloramphenicol Gestodene Sunitinib

Ciclosporin Goserelin Tacrolimus

Cidofovir Histrelin Tamoxifen

Cobimetinib* Ibrutinib Temsirolimus

Colchicine Idelalisib Teriflunomide

Combivir® (Zidovudine/ lamivudine)

Kivexa® (lamivudine/Abacavir) Testosterone

Crizotinib Lapatinib Thalidomide

Dabrafenib Leflunomide Tibolone

Dasatanib Lenalidomide Tofacitinib*

Defibrotide Letrozole Toremifene

Denosumab Leuprorelin Trametinib

Desogestrel Levonorgestrel Trastuzumab

Diethylstilbestrol Lorlatinib* Tretinoin

Dinoprostone Macitentan Triptorelin

Drospirenone Medroxyprogesterone Triumeq® (Doletegravir/abacavir/ lamivudine)

Dutasteride Megestrol Trizivir®* (lamivudine/ zidovudine/abacavir)

Dydrogesterone Menotropins Ulipristal

Efavirenz Mestranol Valganciclovir

Enzalutamide Mifepristone Vandetinib

Ergometrine Mycophenolate Vemurafenib

Erlotinib Nafarelin Vismodegib

Estradiol Nevirapine Zidovudine

Estradiol/dienogest Nilotinib

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Recognised list of Cytotoxic medicines

The following medicines are classed as cytotoxic and are required to be disposed of via the purple waste stream. Staff administering cytotoxic medicines should do so accordance with the Anticancer Medicines Policy AND Guidance on the Management of Patients receiving Cytotoxic Chemotherapy for Non Malignant Conditions. Solid dosage forms of cytotoxic medicines should not be crushed, or intact capsules should not be opened. The presence of a medicine in the below list does not imply that this medicine is available for use on the North of Tyne and Gateshead Formulary or is stocked in NUTH pharmacies.

Actinomycin D Dexrazoxane Paclitaxel

Amsacrine Docetaxel Peg-asparaginase

Arsenic Trioxide Doxorubicin Pegylated Liposomal Doxorubicin

Azacitidine Epirubicin Pemetrexed

Azathioprine Eribulin Pentostatin

Bendmaustine Estramustine Pixantrone

Bleomycin Etoposide Procarbazine

Bortezomib Fludarabine Raltitrexed

Brentuximab vedotin Fluorouracil Streptozocin

Busulfan Gemcitabine Tegafur Uracil

Cabazitaxel Gemtuzumab Temoporfin

Capecitabine Hydroxycarbamide Temozolomide

Carboplatin Idarubicin Teniposide

Carmustine Ifosfamide Thiotepa

Chlorambucil Irinotecan Tioguanine

Cisplatin Lomustine Topotecan

Cladribine Melphalan Trabectedin

Clofarabine Mercaptopurine Trastuzumab emtansine

Crisantaspase Methotrexate Treosulfan

Cyclophosphamide Mitomycin Trifluridine–tipiracil hydrochloride*

Cytarabine Mitotane Vinblastine

Dacarbazine Mitoxantrone Vincristine

Dacitabine Nab-Paclitaxel Vindesine

Dactinomycin Nelarabine Vinflunine

Daunorubicin Oxaliplatin Vinorelbine

The Newcastle upon Tyne Hospitals NHS Foundation Trust

Equality Analysis Form A

This form must be completed and attached to any procedural document when submitted to the appropriate committee for consideration and approval.

PART 1 1. Assessment Date: 2. Name of policy / strategy / service:

Handling, Segregation and Disposal of Cytostatic and Cytotoxic Waste

3. Name and designation of Author:

Matthew Lowery, Formulary Pharmacist

4. Names & designations of those involved in the impact analysis screening process:

Steven Brice, Assistant Director of Pharmacy

5. Is this a: Policy x Strategy Service

Is this: New Revised x

Who is affected Employees x Service Users x Wider Community

6. What are the main aims, objectives of the policy, strategy, or service and the intended outcomes? (These can be cut and pasted from your policy)

This policy aims to ensure the safe handling of cytostatic and cytotoxic medicines that is not covered in other Trust medicines related policies or guidelines.

7. Does this policy, strategy, or service have any equality implications? Yes No x

If No, state reasons and the information used to make this decision, please refer to paragraph 2.3 of the Equality Analysis Guidance before providing reasons:

This policy applies to all members of staff, including locum/agency staff, involved in the supply, administration and disposal of medicines within the Trust.

12.11.18

8. Summary of evidence related to protected characteristics Protected Characteristic Evidence, i.e. What evidence do you have that

the Trust is meeting the needs of people in various protected Groups

Does evidence/engagement highlight areas of direct or indirect discrimination? If yes describe steps to be taken to address (by whom, completion date and review date)

Does the evidence highlight any areas to advance opportunities or foster good relations. If yes what steps will be taken? (by whom, completion date and review date)

Race / Ethnic origin (including gypsies and travellers)

Staff are expected to comply with policy irrespective of their race / ethnic origin.

No No

Sex (male/ female) Staff are expected to comply with policy irrespective of their sex.

No No

Religion and Belief Staff are expected to comply with policy irrespective of their religion and belief.

No No

Sexual orientation including lesbian, gay and bisexual people

Staff are expected to comply with policy irrespective of their sexual orientation.

No No

Age Staff are expected to comply with policy irrespective of their age.

No No

Disability – learning difficulties, physical disability, sensory impairment and mental health. Consider the needs of carers in this section

Staff with physical disabilities will be expected to comply with policy. Staff with learning difficulties, sensory impairment and mental health may be excluded from being involved in handling of cytostatic and cytotoxic medicines. This is appropriate from a safety perspective.

Staff with learning difficulties, sensory impairment and mental health may be excluded from the policy; this is on the grounds of safety.

No

Gender Re-assignment Staff who have had gender re-assignment are expected to comply with policy.

No No

Marriage and Civil Partnership Staff are expected to comply with policy whether they are married, in a civil partnership or single.

No No

Maternity / Pregnancy Staff are expected to comply with policy when pregnant.

No No

9. Are there any gaps in the evidence outlined above? If ‘yes’ how will these be rectified?

No

10. Engagement has taken place with people who have protected characteristics and will continue through the Equality Delivery

System and the Equality Diversity and Human Rights Group. Please note you may require further engagement in respect of any significant changes to policies, new developments and or changes to service delivery. In such circumstances please contact the Equality and Diversity Lead or the Involvement and Equalities Officer.

Do you require further engagement? Yes No x

11. Could the policy, strategy or service have a negative impact on human rights? (E.g. the right to respect for private and family

life, the right to a fair hearing and the right to education?

No.

PART 2 Name:

Matthew Lowery

Date of completion:

12.11.18

(If any reader of this procedural document identifies a potential discriminatory impact that has not been identified, please refer to the Policy Author identified above, together with any suggestions for action required to avoid/reduce the impact.)