Children s Ward & Children s Community Nursing Team: Administration of Goserelin Implant (Zoladex ), Leuprorelin Acetate Depot Injection (Prostap )

Children s Ward & Children s Community Nursing Team: Administration of Goserelin Implant (Zoladex ), Leuprorelin Acetate Depot Injection (Prostap ) and (GnRH) Agonists - Triporelin Clinical Procedure Policy 1

Policy : Children s Ward & Children s Community Nursing Team: Administration of Goserelin Implant (Zoladex ), Leuprorelin Acetate Depot Injection (Prostap ) and (GnRH) Agonists - Triporelin Clinical Procedure Policy Executive Summary and associated documents: For paediatric patients at East Cheshire NHS Trust Zoladex,Prostap SR and Decapeptyl SR and Gonapeptyl depot are used for the treatment of Precocious Puberty. This policy has been developed in response to the increase in medical and nursing staff receiving training to deliver Zoladex, Prostap and Decapeptyl SR and Gonapeptyl depot within the acute hospital setting or the community. It is not mandatory for any staff member to undertake administration of either medication but is encouraged in those who wish to increase their bank of clinical skills. The scope of the policy covers all children from birth up to 18 years of age in line with the East Cheshire NHS Trust Policy for the Admission of Children and Young People age 16 and over to the Children s Ward (2008). Supersedes: Children s Ward & Children s Community Nursing Team: Administration of Goserelin Implant (Zoladex ) and Leuprorelin Acetate Depot Injection (Prostap ) Clinical Procedure Policy November 2014 Description of Amendment(s): Revised policy to incorporate changes in practice and research relevant to this procedure This policy will impact on: All paediatric trust staff Financial Implications: - Policy Area: Paediatrics Document Reference: - ECT002811 Version Number: 1 Effective Date: March 2017 Issued By: - Sr Joanne Doyle Review Date: March 2020 Authors: Dr I Losa (Paediatrician), Sr Joanne Doyle (Team Leader - CCNT) Impact Assessment Date: March 2017 APPROVAL RECORD Committees / Group Date Consultation: CCNT team members, Children s March 2017 Ward Manager, Head of Children s services, Paediatric Clinical lead, Paediatric Consultants responsible for Endocrine patients Approval Committee Paediatrics SQS March 2017 Ratified by Committee/ Executive Director: Paediatrics March 2017 Received for information: March 2017 2

Contents 0.0 Introduction (pg 3) 0.1 Policy & Scope 0.2 Goserelin 0.3 Leuprorelin Acetate 1.4 Triptorelin 1.0 Responsibilities (pg 4) 1.1 Chief Executive 1.2 Head of Children s Services, Children s Ward Manager & Clinical Lead 1.3 Children s Community Nursing Team & Ward Sisters/Consultants 1.4 Clinical Staff 2.0 Principles (pg 4) 3.0 Authority to Proceed (pg 4) 4.0 Consent (pg 5) 5.0 Training/Skills (pg 5) 6.0 Contra-indications (pg 5) 6.1 Zoladex 6.2 Prostap 6.3 Decapeptyl SR and Gonapeptyl depot 7.0 Side Effects (pg 6) 7.1 Zoladex 7.2 Prostap 7.3 Decapeptyl SR and Gonapeptyl depot 8.0 Monitoring (pg 6) 9.0 Procedures (pg 6) 9.1 Procedure for Administration of Zoladex 9.1.1 Equipment required 9.1.2 Prior to Administration 9.1.3 Procedure 9.2 Procedure for Administration of Prostap 9.2.1 Equipment required 9.2.2 Prior to Administration 9.2.3 Procedure 9.3 Procedure for Administration of Triptorelin 9.3.1 Equipment Required 9.3.2 Prior to Administration 9.3.3 Procedure 9.3.4 Further Guidance 10.0 References (pg 10) 3

0.0 Introduction 0.1 Policy & Scope Goserelin, Leuprorelin and Triptorelin are types of hormone therapy drug called lutenizing hormone releasing hormone analogue (LHRHa). Goserelin is also known as Zoladex and shall be referred to as such within this policy, Leuprorelin is also known as Prostap SR DCS and will be referred to as such within this policy and Triptorelin is also known as Decapeptyl SR and Gonapeptyl depot and will be referred to as such within this policy. Each work by interrupting the cycle of hormone production in the body, stopping production of testosterone in men and oestrogen in women. Licensed Indications for GnRH agonist therapy 1. Central precocious puberty due to premature activation of the hypothalamic pituitary gonadal axis. This is generally idiopathic, but may occur as a result of intracranial tumours, following radiotherapy or in association with developmental brain abnormalities, brain injury or certain rare syndromes. 2. In cases where puberty needs to be delayed in order to maximise growth potential in growth hormone deficient children. For paediatric patients at East Cheshire NHS Trust Zoladex,Prostap SR and Decapeptyl SR and Gonapeptyl depot are used for the treatment of Precocious Puberty. This policy has been developed in response to the increase in medical and nursing staff receiving training to deliver Zoladex, Prostap and Decapeptyl SR and Gonapeptyl depot within the acute hospital setting or the community. It is not mandatory for any staff member to undertake administration of either medication but is encouraged in those who wish to increase their bank of clinical skills. The scope of the policy covers all children from birth up to 18 years of age in line with the East Cheshire NHS Trust Policy for the Admission of Children and Young People age 16 and over to the Children s Ward (2008) 0.2 Goserelin (Zoladex ) Zoladex is designed for subcutaneous implantation which provides continuous release over a 12 week period. The implant is presented as a pre-filled syringe applicator containing Goserelin Acetate and is available in two doses; 3.6mg or 10.8mg. Once prescribed by a medical practitioner Zoladex is injected subcutaneously into the patient s thigh by a trained health professional. 0.3 Leuprorelin Acetate (Prostap SR DCS) Prostap SR DCS is designed for both subcutaneous or intra-muscular injection on a monthly basis. It is presented as a powder and solvent for prolonged-release suspension for injection in a prefilled syringe at a dose of 3.75mg or 11.25mg. 0.4 Decapeptyl SR and Gonapeptyl depot Triptorelin is designed for both subcutaneous or intra-muscular injection however subcutaneous injection is the preferred method of administration. It is presented as a powder and solvent for suspension for injection. Triptorelin (Gonapeptyl Depot) 3.75mg should be administered every 3-4 weeks. Triptorelin (Decapeptyl SR) 11.25mg should be administered every 10-12 weeks. Supporting information for Use of Gonadotrophin Releasing Hormone (GnRH) Agonists Triptorelin. The salient features of the two preparations are as follows: 4

Salient features Triptorelin 3.75 mg (Gonapeptyl Depot 3.75 mg) Triptorelin 11.25 mg (Decapeptyl SR 11.25 mg) Dose & injection frequency 3.75 mg every 3-4 weeks 11.25 mg every 10-12 weeks Route of administration Sub-cutaneous injection preferred. Can be given as an intra-muscular injection Deep intra-muscular injection 1 Responsibilities 1.3 Chief Executive The Trust Chief Executive has overall responsibility for the implementation of this policy and to ensure that proper training is in place so that medical and nursing staff can fulfil their duties in accordance with this policy. 1.4 Head of Children s Services/Clinical Matron The Head of Children s Services has a responsibility for the operational implementation of this policy and associated procedures. They will ensure that the policy and training is made available to all doctors and nurses whose role it is to administer the injections. They will also monitor the implementation of a robust risk assessment approach to the administration of both Zoladex and Prostap SR DCS in the community and acute hospital setting through audit of clinical and non- clinical records 1.5 Children s Community Nursing Team & Ward Sisters/Consultants Children s Community Nursing Team (CCNT) & Ward Sisters will ensure that all nursing staff wishing to deliver Zoladex, Prostap SR DCS and Decapeptyl SR and Gonapeptyl depot have sufficient training to do so and have been signed off as competent. There is a named Paediatric Consultant with Endocrine specialism who will oversee and provide this training and maintain responsibility for the patients affected by this policy. The named Consultant can alter the frequency of injections based on clinical/pubertal changes and biochemical levels. 1.6 Clinical Staff All healthcare professionals are responsible for their own actions and must exercise their own personal judgement at all times. Any clinical decision to deviate from this policy and associated procedures must be clearly documented in the medical and/or nursing records for the patient including the reason for variance and any subsequent action taken. All clinical staff have a duty to take all reasonable measures to take care of their own and the patient s safety whilst administering Zoladex, Prostap SR DCS and Decapeptyl SR and Gonapeptyl depot. 2 Principles 2.3 Principles of Health and Safety relating to storage, administration and disposal of medications will be adhered to with reference to appropriate organisational policies. 2.4 Principles relating to prevention of cross infection will underpin practice with reference to appropriate organisational policies. 2.5 Principles relating to consent should be considered alongside this policy with reference to appropriate organisational and national policies. 2.6 Patients should be encouraged to have choice in whether their injection is given in the community or in the acute hospital setting. 5

3 Authority to Proceed 3.3 Treatment should be prescribed by a medical practitioner. 3.4 Authorisation from the patient s consultant must be obtained prior to the procedure being performed. 3.5 Treatment should only be given by trained clinical staff that are competent to proceed. 4 Consent 4.3 Patient/parental consent should be obtained prior to administration of either injection. Although some older children may have the capacity to grant or refuse consent for the treatment younger children may rely solely on the capacity of his/her parents to act in his/her best interest. The patient/parent must be given all the information required to make an informed decision. The wishes of a young person who is deemed to have capacity to consent for themselves must always be considered (East Cheshire NHS Trust Consent to Examination or Treatment Policy 2016). 5 Training/Skills 5.3 Any staff wishing to administer Zoladex, Prostap SR DCS and/or Decapeptyl SR and Gonapeptyl depot must receive initial training by Endocrine Specialist Nurse or Paediatric Consultant, or attend an authorised study day at an alternative Trust. 5.4 Any staff wishing to administer Zoladex, Prostap SR DCS and or Decapeptyl SR and Gonapeptyl depot must complete a self-assessment and then be supervised on three occasions before being seemed competent to administer the injections unsupervised. 5.5 All staff who have received training in the administration of Zoladex, Prostap SR DCS and or Decapeptyl SR and Gonapeptyl depot must complete yearly competency forms as part of the trust appraisal process. See links below; 6 Contra-indications 6.3 Zoladex Zoladex should not be given to patients with a known hypersensitivity to the active substance or excipients of Zoladex Zoladex is contra-indicated with known or suspected pregnancy and lactation and undiagnosed vaginal bleeding. 6.4 Prostap SR DCS Prostap SR DCS should not be given to patients with a known hypersensitivity to the active substance or excipients of Prostap Prostap SR DCS is contra-indicated in women who are or may become pregnant whilst receiving the drug. Prostap SR DCS should not be used in women who are breastfeeding or undiagnosed abnormal vaginal bleeding. 6.5 Decapeptyl SR and Gonapeptyl depot Decapeptyl SR and Gonapeptyl depot should not be used in women with undiagnosed vaginal bleeding. Decapeptyl SR and Gonapeptyl depot should be avoided if pregnant or breastfeeding. 6

7 Side Effects 7.3 Zoladex Hypersensitivity reactions, hot flushes, sweating, sexual dysfunction, vaginal dryness, gynaecomastia or changes in breast size, headaches, Gastro-intestinal disturbances, sleep disturbances, mood changes, Mild vaginal bleed (especially after the first dose). See manufacturer information for detailed side effects. 7.4 Prostap SR DCS In children: emotional lability, headache, abdominal pain/cramps, nausea, vomiting, allergic reaction (rare). See manufacturer information for detailed side effects. 7.5 Decapeptyl SR and Gonapeptyl depot Mild/moderate vaginal bleeding may occur in girls in the first month of treatment. Concurrent use of cyproterone acetate for the first 2 weeks can minimise the risk of vaginal bleeding. Injection site reactions and arthralgia. See manufacturer information for detailed side effects. 8 Monitoring 8.3 This Policy will be reviewed on a three yearly basis by the author/practice Development Nurse/Ward Sister as appropriate in conjunction with the Paediatric Consultant responsible for Endocrine patients. 8.4 Any changes required will be made along with amendments to the competency forms and trained staff will be required to complete new competencies. 9 Procedures 9.3 Procedure for Administration of Zoladex 9.3.1 Equipment required Correct prescription Sterile Gloves Apron Blue/Purple plastic ANTT tray Alcohol wipe Gauze Swabs ChloraPrep skin cleanser Drug Emergency adrenaline Sharps bin Sterile plaster Disposal bag 9.3.2 Prior to Administration 1 hour prior to administration, the patient or carer may wish to apply a layer of Ametop Cream (1-5 hours prior if using EMLA cream) to the injection site. The cream should be covered with an occlusive dressing. 9.3.3 Procedure 1. Read patient notes & ensure correct prescription is available. 2. Explain procedure and possible side effects to patient and gain verbal consent to proceed. 7

3. Ensure patient is in comfortable position and upper body is slightly raised. 4. Wash hands and put on protective gloves and apron. 5. Prepare equipment onto ANTT tray which has been cleaned with alcohol wipe. 6. Remove occlusive dressing and wipe away Ametop/EMLA cream with gauze swabs (if required) 7. Cleanse injection site with ChloraPrep and leave to dry for 30 seconds. 8. Wash Hands and put on protective gloves. 9. Open foil packaging as directed and remove the syringe checking expiry date of medication. 10. Check that the depot is visible in the window of the syringe. Do not try and remove air as this is not a liquid injection. 11. Remove the plastic safety tab away from the syringe and discard. 12. Remove needle cover. 13. Hold the syringe around the barrel using Aseptic Non Touch Technique (ANTT); pinch the skin around the injection site. 14. With the bevel of the needle facing upwards, insert the needle at a 30-45 degree angle to the skin in one continuous deliberate motion until the protective sleeve touches the patient s skin. 15. Administer the Zoladex implant by depressing the plunger until you can depress it no further, activating the protective shield. You may hear a click and you will feel the protective shield automatically begin to slide and cover the needle. 16. Withdraw the syringe and allow the protective shield to slide and cover the needle. 17. Dispose of the syringe in a sharps box. 18. Cover the injection site with a sterile non adherent dressing. 19. Dispose of remaining rubbish is disposal bag. 20. Record the injection in the patient record, noting drug dosage, batch number, expiry date and injection site. 21. Arrange next appointment for patient. 9.4 Procedure for Administration of Prostap SR DCS 9.4.1 Equipment required Correct prescription Sterile Gloves Apron Blue/Purple plastic ANTT tray Alcohol wipe Gauze Swabs ChloraPrep skin cleanser Drug Emergency adrenaline Sharps bin Sterile plaster Disposal bag 9.4.2 Prior to Administration 1 hour prior to administration, the patient or carer may wish to apply a layer of Ametop Cream (1-5 hours prior if using EMLA cream) to the injection site. The cream should be covered with an occlusive dressing. 9.4.3 Procedure 1. Read patient notes & ensure correct prescription is available. 2. Explain procedure and possible side effects to patient and gain verbal consent to proceed. 3. Ensure patient is in comfortable position and upper body is slightly raised. 4. Wash hands and put on protective apron and gloves. 5. Prepare equipment onto ANTT tray which has been cleaned with alcohol wipe. 8

6. Remove occlusive dressing and wipe away Ametop/EMLA cream with gauze swabs (if required) 7. Wash Hands and put on protective gloves. 8. Remove administration device from packaging checking expiry date. 9. Screw the plunger rod into the end stopper until the stopper begins to turn. 10. Check that the needle is tight by twisting the needle cap clockwise. Do not over tighten. 11. Holding the syringe upright, release the dilutents by slowly pushing the plunger until the middle stopper is at the blue line in the middle of the barrel. 12. Gently tap the syringe on the palm keeping the syringe upright to thoroughly mix the particles to form a uniform suspension. The suspension will appear milky. 13. Remove the needle cap and advance the plunger to expel the air from the syringe. 14. At the time of the injection check the direction of the safety device (round mark should face upwards) and inject the entire contents of the syringe subcutaneously or intramuscularly. 15. Withdraw the needle from the patient and immediately activate the safety device by pushing the arrow forward with the thumb or finger until the device is fully extended and a click is heard or felt. 16. Dispose of the syringe in a sharps box. 17. Cover the injection site with a sterile non adherent dressing. 18. Dispose of remaining rubbish is disposal bag. 19. Record the injection in the patient record, noting drug dosage, batch number, expiry date and injection site. 20. Arrange next appointment for patient. 9.5 Procedure for Administration of Decapeptyl SR and Gonapeptyl depot 9.5.1 Equipment required Correct prescription Sterile Gloves Apron Blue/Purple plastic ANTT tray Alcohol wipe Gauze Swabs ChloraPrep skin cleanser Drug Emergency adrenaline Sharps bin Sterile plaster Disposal bag 9.5.2 Prior to Administration It is important to ensure that the injections are given within the recommended time interval and any delay should be avoided. Pubertal suppression action of GnRH agonists may be lost if injections are unduly delayed and increases the incidence of adverse effects. The injection can be brought forward for a few days if required. 1 hour prior to administration, the patient or carer may wish to apply a layer of Ametop Cream (1-5 hours prior if using EMLA cream) to the injection site. The cream should be covered with an occlusive dressing. 9.5.3 Procedure 1. Read patient notes & ensure correct prescription is available. 2. Explain procedure and possible side effects to patient and gain verbal consent to proceed. 3. Ensure patient is in comfortable position and upper body is slightly raised. 9

4. Gather all drugs and equipment reconstitution should only be done with the provided solution and needles should be changed for withdrawing the solution and giving the injection as per manufacturers recommendations. 4. Wash hands and put on protective apron and gloves. 5. Prepare equipment onto ANTT tray which has been cleaned with alcohol wipe. 6. Remove occlusive dressing and wipe away Ametop/EMLA cream with gauze swabs (if required) 7. Wash Hands and put on protective gloves. 8. Clean area of skin with ChloraPrep skin cleanser and leave to dry for 30 seconds. 9. Administer subcutaneous or intra-muscular injection as prescribed. 10. Dispose of the syringe in a sharps box. 11. Cover the injection site with a sterile non adherent dressing. 12. Dispose of remaining rubbish is disposal bag. 13. Record the injection in the patient record, noting drug dosage, batch number, expiry date and injection site. 24. Arrange next appointment for patient. 9.5.4 Further guidance available at; http://www.bsped.org.uk/clinical/docs/gnrh_agonistssharedcareguidelines-july2015.pdf 10.0 References NHS Walsall Community Health Administration of Goserelin Implant (Zoladex) Clinical Procedure Policy (2009) Takeda (UK) Ltd Prostap*SRDCS Health Professionals User Leaflet (2012) AstraZeneca Information leaflet: Zoladex 3.6mg Implant (2014) AstraZeneca Information leaflet: Zoladex LA 10.8mg Implant (2014) BNF for children (2016-2017) BSPED Clinical Committee, Shared Care Guideline: Use of Gonadotrophin Releasing Hormone Agonists Triptorelin (July 2015) East Cheshire NHS Trust Consent to Treatment and Examination Policy (March 2016) 10

10 Equality Analysis Equality Analysis (Impact assessment) Please START this assessment BEFORE writing your policy, procedure, proposal, strategy or service so that you can identify any adverse impacts and include action to mitigate these in your finished policy, procedure, proposal, strategy or service. Use it to help you develop fair and equal services. Eg. If there is an impact on Deaf people, then include in the policy how Deaf people will have equal access. 1. What is being assessed? Children s Ward & Children s Community Nursing Team: Administration of Goserelin Implant (Zoladex ) and Leuprorelin Acetate Depot Injection (Prostap SR DCS) Clinical Procedure Policy Details of person responsible for completing the assessment: Name: Joanne Doyle Job Title: Sister Team: Children s Community Nursing Team State main purpose or aim of the policy, procedure, proposal, strategy or service: (usually the first paragraph of what you are writing. Also include details of legislation, guidance, regulations etc which have shaped or informed the document) Goserelin and Leuprorelin are types of hormone therapy drug called lutenizing hormone releasing hormone analogue (LHRHa). Goserelin is also known as Zoladex and shall be referred to as such within this policy whilst Leuprorelin is also known as Prostap and will be referred to as such within this policy. Both work by interrupting the cycle of hormone production in the body, stopping production of testosterone in men and oestrogen in women. They are used in the management of prostatic cancer, early or advanced breast cancer (suitable for hormonal manipulation) and for some benign gynaecological conditions such as endometriosis, fibroids and for pre thinning of the uterine endometrium. For paediatric patients at East Cheshire NHS Trust Zoladex and Prostap SR are used for the treatment of Precocious Puberty. This policy has been developed in response to the increase in medical and nursing staff receiving training to deliver both Zoladex and Prostap within the acute hospital setting or the community. It is not mandatory for any staff member to undertake administration of either medication but is encouraged in those who wish to increase their bank of clinical skills. The scope of the policy covers all children from birth up to 18 years of age in line with the East Cheshire NHS Trust Policy for the Admission of Children and Young People age 16 and over to the Children s Ward (2008) 2. Consideration of Data and Research To carry out the equality analysis you will need to consider information about the people who use the service and the staff that provide it. Think about the information below how does this apply to your policy, procedure, proposal, strategy or service 2.1 Give details of RELEVANT information available that gives you an understanding of who will be affected by this document Cheshire East (CE) covers Eastern Cheshire CCG and South Cheshire CCG. Cheshire West & Chester (CWAC) covers Vale Royal CCG and Cheshire West CCG. In 2011, 370,100 people resided in CE and 329,608 people resided in CWAC. 11

Age: East Cheshire and South Cheshire CCG s serve a predominantly older population than the national average, with 19.3% aged over 65 (71,400 people) and 2.6% aged over 85 (9,700 people). Vale Royal CCGs registered population in general has a younger age profile compared to the CWAC average, with 14% aged over 65 (14,561 people) and 2% aged over 85 (2,111 people). Since the 2001 census the number of over 65s has increased by 26% compared with 20% nationally. The number of over 85s has increased by 35% compared with 24% nationally. Race: In 2011, 93.6% of CE residents, and 94.7% of CWAC residents were White British 5.1% of CE residents, and 4.9% of CWAC residents were born outside the UK Poland and India being the most common 3% of CE households have members for whom English is not the main language (11,103 people) and 1.2% of CWAC households have no people for whom English is their main language. Gypsies & travellers estimated 18,600 in England in 2011. Gender: In 2011, c. 49% of the population in both CE and CWAC were male and 51% female. For CE, the assumption from national figures is that 20 per 100,000 are likely to be transgender and for CWAC 1,500 transgender people will be living in the CWAC area. Disability: In 2011, 7.9% of the population in CE and 8.7% in CWAC had a long term health problem or disability In CE, there are c.4500 people aged 65+ with dementia, and c.1430 aged 65+ with dementia in CWAC. 1 in 20 people over 65 has a form of dementia Over 10 million (c. 1 in 6) people in the UK have a degree of hearing impairment or deafness. C. 2 million people in the UK have visual impairment, of these around 365,000 are registered as blind or partially sighted. In CE, it is estimated that around 7000 people have learning disabilities and 6500 people in CWAC. Mental health 1 in 4 will have mental health problems at some time in their lives. Sexual Orientation: CE - In 2011, the lesbian, gay, bisexual and transgender (LGBT) population in CE was estimated at18,700, based on assumptions that 5-7% of the population are likely to be lesbian, gay or bisexual and 20 per 100,000 are likely to be transgender (The Lesbian & Gay Foundation). CWAC - In 2011, the LGBT population in CWAC is unknown, but in 2010 there were c. 20,000 LGB people in the area and as many as 1,500 transgender people residing in CWAC. Religion/Belief: The proportion of CE people classing themselves as Christian has fallen from 80.3% in 2001 to 68.9% In 2011 and in CWAC a similar picture from 80.7% to 70.1%, the proportion saying they had no religion doubled in both areas from around 11%-22%. Christian: 68.9% of Cheshire East and 70.1% of Cheshire West & Chester Sikh: 0.07% of Cheshire East and 0.1% of Cheshire West & Chester Buddhist: 0.24% of Cheshire East and 0.2% of Cheshire West & Chester Hindu: 0.36% of Cheshire East and 0.2% of Cheshire West & Chester Jewish: 0.16% of Cheshire East and 0.1% of Cheshire West & Chester Muslim: 0.66% of Cheshire East and 0.5% of Cheshire West & Chester Other: 0.29% of Cheshire East and 0.3% of Cheshire West & Chester None: 22.69%of Cheshire East and 22.0% of Cheshire West & Chester 12

Not stated: 6.66% of Cheshire East and 6.5% of Cheshire West & Chester Carers: In 2011, nearly 11% (40,000) of the population in CE are unpaid carers and just over 11% (37,000) of the population in CWAC. 2.2 Evidence of complaints on grounds of discrimination: (Are there any complaints or concerns raised either from patients or staff (grievance) relating to the policy, procedure, proposal, strategy or service or its effects on different groups?) Nil 2.3 Does the information gathered from 2.1 2.3 indicate any negative impact as a result of this document? Nil 3. Assessment of Impact Now that you have looked at the purpose, etc. of the policy, procedure, proposal, strategy or service (part 1) and looked at the data and research you have (part 2), this section asks you to assess the impact of the policy, procedure, proposal, strategy or service on each of the strands listed below. RACE: From the evidence available does the policy, procedure, proposal, strategy or service affect, or have the potential to affect, racial groups differently? Yes No X This policy is to cover paediatric patients receiving Zoladex and Prostap SR. All patients will be considered for the treatment regardless of race. If a patient or carer s first language is not English, staff will follow the trust interpretation policy. GENDER (INCLUDING TRANSGENDER): From the evidence available does the policy, procedure, proposal, strategy or service affect, or have the potential to affect, different gender groups differently? Yes No X This policy is to cover paediatric patients receiving Zoladex and Prostap SR. All patients will be considered for the treatment regardless of gender DISABILITY From the evidence available does the policy, procedure, proposal, strategy or service affect, or have the potential to affect, disabled people differently? Yes No X This policy is to cover paediatric patients receiving Zoladex and Prostap SR. All patients will be considered for the treatment regardless of disability. AGE: From the evidence available does the policy, procedure, proposal, strategy or service, affect, or have the potential to affect, age groups differently? Yes No X 13

This policy is to cover paediatric patients receiving Zoladex and Prostap SR. All patients will be considered for the treatment regardless of age. LESBIAN, GAY, BISEXUAL: From the evidence available does the policy, procedure, proposal, strategy or service affect, or have the potential to affect, lesbian, gay or bisexual groups differently? Yes No X This policy is to cover paediatric patients receiving Zoladex and Prostap SR. All patients will be considered for the treatment regardless of sexual orientation. RELIGION/BELIEF: From the evidence available does the policy, procedure, proposal, strategy or service affect, or have the potential to affect, religious belief groups differently? Yes No X This policy is to cover paediatric patients receiving Zoladex and Prostap SR. All patients will be considered for the treatment regardless of religion/belief. For patients of different cultures and beliefs, staff will check the content of the drug and discuss this with the patient and carer if a conflict is identified, eg porcine products and Muslim patients. CARERS: From the evidence available does the policy, procedure, proposal, strategy or service affect, or have the potential to affect, carers differently? Yes No X This policy is to cover paediatric patients receiving Zoladex and Prostap SR. All patients will be considered for the treatment and carers involved in information and explanation as appropriate to support the patient. OTHER: EG Pregnant women, people in civil partnerships, human rights issues. From the evidence available does the policy, procedure, proposal, strategy or service affect, or have the potential to affect any other groups differently? Yes No X No patient will be discriminated against on any grounds. 4. Safeguarding Assessment - CHILDREN a. Is there a direct or indirect impact upon children? Yes X No b. If yes please describe the nature and level of the impact (consideration to be given to all children; children in a specific group or area, or individual children. As well as consideration of impact now or in the future; competing / conflicting impact between different groups of children and young people: These guidelines are designed to be used for all young people up to age 18 and will therefore impact on all these children. c. If no please describe why there is considered to be no impact / significant impact on children 14

5. Relevant consultation Having identified key groups, how have you consulted with them to find out their views and that the made sure that the policy, procedure, proposal, strategy or service will affect them in the way that you intend? Have you spoken to staff groups, charities, national organisations etc? Groups identified for consultation: Community Service Managers Children s Services Manager Children s Ward Matron Children s Community Nursing Team Children s Ward Sisters Paediatric Consultants 6. Date completed: March 2017 Review Date: March 2020 7. Any actions identified: Have you identified any work which you will need to do in the future to ensure that the document has no adverse impact? Action Lead Date to be Achieved 8. Approval At this point, you should forward the template to the Trust Equality and Diversity Lead lynbailey@nhs.net Approved by Trust Equality and Diversity Lead: Date: April 2017 15