Vaccine Cold Storage Policy

Transcription

1 Vaccine Cold Storage Policy Pharmacy Operational manager Page 1 of 21

2 Policy Title: Vaccine Cold Storage Policy Executive Summary: Supersedes: Version 1.4 Amendments to previous version: This policy will impact on: All Trust Clinical staff This policy forms part of the overall Safe & Secure Handling of Medicines Policy and together with the Standard Operational procedures (SOPs) provide guidance to all Trust staff on the handling and storage of vaccines in accordance with NPSA Rapid Response Alert issued by the National Patient Safety Agency. Amend Service line information Appendix 3 incorporated to the main body of the policy Updated Appendix 3 fridge temperature monitoring table Financial Implications: As a result of the fridge audit, some clinical areas may need new fridges to meet the requirements of this NPSA Alert. Policy Area: Trust Wide Document Reference: Version 1.5 ECT Number: Effective Date: 23 rd March 2017 Issued By: Chief Pharmacist Review Date: 23 rd March 2020 Author: 1 st August 2013 (Full Job title ) Karen Burton Pharmacy Operational Manager APPROVAL RECORD Committees / Group Consultation (Original Policy): Impact Assessment Date: Date Multidisciplinary Group Meeting April 2010 Project Management Group May June 2010 Approved by: Medicines Management Group January 2017 Policy Governance Group Operational Pharmacy Group 11 th July 2013 Kashif Haque (Chief Pharmacist) 11 th July 2013 Pharmacy Operational manager Page 2 of 21

3 Contents: 1. POLICY STATEMENT DEFINITIONS ORGANISATIONAL RESPONSIBILITIES... 5 The Chief Executive... 5 Service lines... 5 Clinical and service managers... 5 Ward/departmental managers... 5 Ward/Departmental staff... 5 Pharmacy staff... 5 Individual Members of Staff PLANNING & IMPLEMENTATION GOVERNANCE MONITORING INCIDENT REPORTING REVIEW MAINTENANCE OF COLD CHAIN IN WARDS AND DEPARTMENTS... 7 Accountability and responsibility... 7 Maintenance of Cold Chain in Pharmacy... 7 Assembly of Ward/Dept Stock Vaccines... 7 To Assemble Ward/Dept Patient Labelled Vaccines... 7 Delivery of Ward/Dept Stock and Patient Labelled Vaccines... 7 Receipt of vaccines on the ward... 7 Fridge maintenance & Monitoring... 8 Fridge Malfunction Fridge maintenance & Monitoring Troubleshooting - Fridge Malfunction... 9 APPENDICES Overview SOP Description Overview Reference to other Operating Procedures General storage/handling Assembly and Delivery of School Health Vaccines Returned Vaccines Appendix 1 - The Assembly and Delivery of Ward/Dept Vaccines within the Hospital Appendix 2 The Assembly and Delivery of GP and School Health Vaccines Appendix 3 Fridge Temperature Monitoring Record Pharmacy Operational manager Page 3 of 21

4 1. POLICY STATEMENT Vaccines must be stored within the temperature range recommended by manufacturers (2 C to 8 C). Incorrect storage of vaccines is not only wasteful and costly to the NHS, the failure to store vaccines correctly, particularly at temperatures below the manufacturers recommendations, can reduce vaccine effectiveness and cause vaccine failures. Freezing may also cause hairline cracks in the container, leading to contamination of the contents. Between January 2005 and April 2009, about 50 million doses of childhood vaccines were distributed in the UK. During this period the National Patient Safety Agency (NPSA) received 260 reports of incidents from a range of NHS organisations related to vaccination cold storage. Themes identified from these reports include: delay in storage of vaccines (especially after delivery); storage at wrong temperature; fridge switched off or broken; power cut or fridge door left open; no temperature monitoring; inadequate or missing equipment; and inappropriate use of domestic fridges. It is unknown if any of these incidents led to significant harm. In June 2009, a primary care trust (PCT) audit of vaccine storage in GP practices was shared with the NPSA. A two-year retrospective audit of 96 practices revealed that a significant proportion of vaccines had been stored outside the recommended temperature range. The CCG did further risk assessment to identify which of the vaccines concerned had the greatest potential for harm (such as vaccines rendered ineffective by freezing). As a result, 560 patients from two practices were recalled for repeat vaccination. These local findings, together with incidents reported to the NPSA, suggest scope for improvement in vaccine storage. As a result of this, the NPSA alert on Vaccine Cold Storage was published on 21 st January 2010 with instruction that NHS organisations should ensure that all departments and providers (including independent contractors) holding vaccine stocks are aware of the NPSA alert and resulting Trust policies on storage of vaccines. The local policy and Standard Operating Procedures designed and implemented should include: Identifying a designated person and deputy/ies responsible for receipt and storage of vaccines. Reviewing refrigerator temperature readings in a manner that will identify if vaccines have been stored outside of manufacturers recommended temperature ranges before they are administered to patients. A trouble-shooting guide for remedial action where vaccines are stored outside manufacturers recommended temperature ranges, and ensure departments and providers are aware of these. 2. DEFINITIONS Vaccinations work by stimulating the immune system, the natural disease-fighting system of the body. The healthy immune system is able to recognize invading bacteria and viruses and produce substances (antibodies) to destroy or disable them. Immunizations prepare the immune system to ward off a disease. To immunize against viral diseases, the virus used in the vaccine has been weakened or killed. To only immunize against bacterial diseases, it is generally possible to use a small portion of the dead bacteria to stimulate the formation of antibodies against the whole bacteria. In addition to the initial immunization process, it has been found that the effectiveness of immunizations can be improved by periodic repeat injections or "boosters." Pharmacy Operational manager Page 4 of 21

5 3. ORGANISATIONAL RESPONSIBILITIES The Chief Executive The responsibility for ensuring that the policy for Vaccine Cold Storage is being adhered to ultimately rests with the Chief Executive who may delegate this to the Director of Nursing, Performance & Quality and they MUST ensure action is taken in response to deficiencies reported following audit reviews/incidents/areas of concern expressed by their staff or the Pharmacy department. Service lines It is the responsibility of the Clinical and Associate directors of the Service lines to ensure that all staff are trained to carry out the tasks required of them as highlighted in the Trust Policy for Vaccine Cold Storage. Clinical and service managers Will oversee the application of this policy into their services and ensure its implementation is undertaken within their management structure, with the necessary controls to achieve the policy s aim. They will liaise with members of the Pharmacy department to obtain expert advice when necessary. They will promote the policy to their teams. Ward/departmental managers Are responsible for ensuring:- All staff have read and understood the Trust Policy on Vaccine Cold Storage, and the associated Standard Operating Procedures for maintenance of cold chain. Daily checks of the refrigerator are undertaken. The refrigerator is maintained in good, clean working order Identify any areas of significant risk and take action to control the risk Ward/Departmental staff Have a responsibility to:- Adhere to all policies and procedures for Vaccine Cold Storage. Support the ward manager in ensuring that the Trust procedures for Vaccine Cold Storage and maintenance of cold chain are being followed. Have ward SOPs in place for contingency against fridge failure Report all incidents involving vaccines stored outside of the cold chain to the nurse/midwife in charge and complete a green drug incident report form. Pharmacy staff Are responsible for:- Providing information and advice to Trust personnel on the stability of vaccines if stored outside of the cold chain. Pharmacy Operational manager Page 5 of 21

6 Individual Members of Staff All members of staff involved in delivery of the service relating to Vaccine Cold Storage MUST keep up to date with this Policy and the relevant associated procedures. Changes/updates to this policy will be communicated to staff via the mechanism of and updated policy on the Trust Intranet. All staff will be required to sign that they have read and understood the policy and will abide by this. A form for this purpose will be held in each ward/area handling vaccines. 4. PLANNING & IMPLEMENTATION This policy will be approved by Medicines Management Group. The policy once approved will be ratified by the Director of Nursing, Performance & Quality. The Chief Pharmacist will be responsible for informing the Trust of the publication of the policy and managing the implementation. All Clinical and service managers, Ward and department managers will be sent a copy of this policy to identify the change in policy guidance. This may be cascaded through the Clinical and Associate directors of the business units. The policy will be uploaded onto the Trust internet and an with a hyperlink to the policy will be sent to all staff. It is the responsibility of the ward and department managers to inform their staff of any changes in the policy. 5. GOVERNANCE Trust Policy in place reviewed every 3 years. Standard operational procedures (SOPs) will include the preservation of the vaccine cold chain at ward level, assembly and delivery of vaccines from Pharmacy to wards and departments within the hospital, and assembly and delivery of vaccines from Pharmacy to GP surgeries and during the school health programmes. These SOPs will cover the responsibilities within the Pharmacy and the interface with the wards/department. All SOPs should be approved by the Chief Pharmacist for the Trust. Where the Trust provides services to another Trust or organisation, responsibility for governance arrangements should be specified in the contract or service level agreement. 6. MONITORING The Care Quality Commission will be using their existing self-assessment methods to assess whether Healthcare Organisations are meeting National Standards. The Care Quality Commission working under the direction of the Health & Social Care Act 2008 (Regulations 2009) will report specifically on any points of concern about conformation to NPSA Rapid Response Alerts. They will do this as part of their routine assessment of whether a Trust is meeting core standards and through the clinical audit programme. 7. INCIDENT REPORTING The Trust Incident Reporting system should be used to record any incidents or near misses relating to any aspect of vaccines and cold storage/ maintenance of cold chain. These should be completed using the Trust Incident Reporting System (Datix). 8. REVIEW Audit Framework - A 12 month audit will be carried out by Ward Pharmacy staff to audit compliance with the NPSA alert for Vaccine Cold Storage on wards/departments and in the Pharmacy This Audit report will be presented to the Risk group. Pharmacy Operational manager Page 6 of 21

7 9. MAINTENANCE OF COLD CHAIN IN WARDS AND DEPARTMENTS Accountability and responsibility The registered nurse, midwife, Pharmacist, Pharmacy Technician or Pharmacy Assistant Technical Officer is responsible for the maintenance of the cold chain for vaccines. The designated person accountable for this will be the Ward/ Departmental Manager or designated deputies. Maintenance of Cold Chain in Pharmacy All vaccines must be kept between 2 C and 8 C, the cold chain must be maintained at all times. Daily monitoring of refrigerators ensures that the storage temperatures are within these limits. Vaccines are obtained from Movianto through Healthcare Logistics in refrigerated vehicles. On receipt, a vaccine order must be checked and stored immediately in the Pharmacy Cold Room. Assembly of Ward/Dept Stock Vaccines A separate request/distribution is raised on ipharmacy for the area requiring the vaccine(s). The required vaccine(s) are picked from the cold store as detailed on the picking list. The vaccine(s) and the delivery note are placed into a yellow fridge bag. The bag is sealed and labelled with vaccines enclosed-refrigerate on receipt on the outside of the bag. The consignment note book is completed and the delivery detailed on the porters board located in the goods out area. To Assemble Ward/Dept Patient Labelled Vaccines The required vaccine(s) are dispensed and labelled required as directed in the dispensing procedure. A yellow bag is prepared with a label stating vaccines enclosed-refrigerate on receipt and placed inside a dispensing tray. The tray is placed in the accuracy checking area. The dispensed vaccines are placed in the dispensary fridge whilst awaiting an accuracy check. The consignment note book is completed and the delivery detailed on the porters board located in the goods out area. When the accuracy check has been completed, the vaccines are placed in the yellow bag. The yellow bag is sealed and then placed in the distribution area cold store. Delivery of Ward/Dept Stock and Patient Labelled Vaccines The pharmacy porter will request the Assistant Technical Officer working within the distribution area to retrieve the appropriate order from the cold store. The porter will sign the consignment note book and the top copy taken with the vaccine(s) to the ward/dept. The porter is to gain a signature from the designated member of staff on delivery. The completed consignment note is to be returned to the pharmacy dept by the porter and filed alongside the picking list/requisition. Receipt of vaccines on the ward Upon delivery of the vaccine to the ward/ clinical area, the designated person will immediately place the vaccine in the fridge situated in the clinical area. The vaccine must not be left at room temperature. Pharmacy Operational manager Page 7 of 21

8 Fridge maintenance & Monitoring It is the responsibility of the Ward Manager/ Designated person to ensure the fridges in all clinical areas storing vaccines are in good working order, have uninterrupted electrical supply, be clean, and have min./ max temperature monitoring facilities. Uninterrupted electrical supply can be achieved by using a switchless socket or by placing cautionary notices on plugs and sockets. Temperatures in the fridge MUST be monitored at least once a day and documented on a chart for recording temperatures. If fridge maintenance is required, an approved cool box or alternative vaccine fridge should be used to store vaccines in. Use of a domestic fridge is not acceptable. Fridge Malfunction Without opening the fridge door, the temperature of the fridge must be noted using the fridge temperature monitoring equipment. Fridge downtime can be estimated from the last temperature recording that was in range. The electrical supply to the fridge must be checked. If disconnected, it must be reconnected immediately. If the electrical supply is still connected and the fridge is still not working, call Estates and remove vaccines from the fridge. Quarantine the vaccines and place them immediately into an alternative vaccine fridge. Refrigeration information can be found on the specialist Pharmacy service website searching under the drug name or Pharmacy Medicines Information on Ext Replacement stock can be ordered via Pharmacy Stores Order Line on Ext PRESERVATION OF COLD CHAIN FOR VACCINES AT WARD LEVEL 10.1 Fridge maintenance & Monitoring It is the responsibility of the Ward Manager/ Designated person to ensure the fridges in all clinical areas storing vaccines are in good working order, have uninterrupted electrical supply, be clean, and have min./ max temperature monitoring facilities. Uninterrupted electrical supply can be achieved by using a switchless socket (recommended contact Estates to arrange) or by placing cautionary notices on plugs and sockets. Temperatures in the fridge MUST be monitored at least once a day and documented on a chart for recording temperatures (See Appendix 3 Vaccine Cold Storage Policy). This chart must have the date and time the temperature was recorded, details of the minimum and maximum temperature, and the signature and printed name of the person who has made the entry. If the fridge needs defrosting or cleaning, an approved cool box or alternative fridge should be used to store vaccines in. As soon as the fridge returns to within normal refrigeration temperature (i.e.2 o C 8 o C), return the vaccines to the fridge. Pharmacy Operational manager Page 8 of 21

9 10.2 Troubleshooting - Fridge Malfunction Without opening the fridge door, record the temperature of the fridge (using the temperature monitoring equipment) and estimate fridge downtime from the last temperature recording that was in range. Check the fridge has not been disconnected from the electrical supply. If so, reconnect immediately. If the electrical supply is still connected and the fridge is still not working, call Estates and remove vaccines from the fridge. Quarantine the vaccines and place them immediately into an alternative suitable fridge. Refrigeration information can be found on the specialist Pharmacy service website searching under the drug name or Pharmacy Medicines Information on Ext Replacement stock can be ordered via Pharmacy Stores Order Line on Ext Pharmacy Operational manager Page 9 of 21

10 APPENDICES Appendix 1 - The Assembly and Delivery of Ward/Dept Vaccines within the Hospital SOP Title: Executive Summary: The Assembly and Delivery of Ward/Dept Vaccines within the Hospital Assembling and delivering vaccines to wards and departments within the hospital, ensuring the cold chain is maintained at all times. Supersedes: 0.3 Description of Amendment(s): Amended accorded to good distribution practice This SOP will impact on: Pharmacists, pharmacy technicians and nursing staff working at East Cheshire NHS Trust. Financial Implications: Efficient handling of vaccines will reduce wastage. Procedural area: Stores & Distribution Document Reference: SD001 Version Number: 0.4 Effective Date: 30 JUN 2015 Author: CONSULTATION Committees / Group/Job title Senior Technician Purchasing and Distribution WDL- Approved by responsible person Senr. Management Team Other (please specify) APPROVAL Review Date: 30 JUN 2017 Date Pharmacy Operational manager Page 10 of 21

11 SOP Locations: Copies of this SOP are stored in (tick in relevant box): Dispensary Technical Services Administration Clinical check bench Purchasing office General office (Master copy) Aseptic services Distribution area On call file Main dispensing Repackaging unit On call CD-ROM area office Secure Room Repackaging unit Master induction file rooms Medicines information Overview This SOP is concerned with: assembling and delivering vaccines to wards and departments within the hospital, ensuring the cold chain is maintained at all times. SOP Description General storage/handling All vaccines must be kept between 2 C and 8 C, the cold chain must be maintained at all times. Daily monitoring of refrigerators ensures that the storage temperatures are within these limits. Vaccines are obtained from Movianto through Healthcare Logistics in refrigerated vehicles. On receipt, a vaccine order must be checked and stored immediately. Qualified equipment should be used to ensure correct transport conditions are maintained. To Assemble Ward/Dept Stock Vaccines 1. Raise a separate request/distribution on ipharmacy for the area requiring the vaccine(s). 2. Pick the required vaccine(s) from the cold store as detailed on the picking list. 3. Place the vaccine(s) and the delivery note into a yellow fridge bag, seal the bag and place a label on the outside of the bag stating vaccines enclosed-refrigerate on receipt. 4. Complete the consignment note book. 5. Detail the delivery on the porters board located in the goods out area. To Assemble Ward/Dept Patient Labelled Vaccines 1. Dispense and label the vaccine(s) required as directed in the dispensing procedure. 2. Place a label on the outside of a yellow bag stating vaccines enclosed-refrigerate on receipt. 3. Place the yellow bag inside the dispensing tray and leave the tray on the accuracy checking area. 4. Place the vaccines in the dispensary fridge whilst awaiting an accuracy check 5. Complete the consignment note book. 6. Detail the delivery on the porters board located in the goods out area. 7. After the vaccines have been accuracy checked the accuracy checker is to place the sealed bag in the distribution area cold store. Pharmacy Operational manager Page 11 of 21

12 Delivery of Ward/Dept Stock and Patient Labelled Vaccines 1. On request from the pharmacy porter the Assistant Technical Officer working within the distribution area is to select the appropriate order from the cold store. 2. The consignment note book is signed by the porter and the top copy taken with the vaccine(s) to the ward/dept. 3. The porter is to gain a signature from a member of staff on delivery. 4. The completed consignment note is to be returned to the pharmacy dept by the porter and filed alongside the picking list/requisition. Receipt of Vaccines at Ward/dept Level 1. On arrival at the ward/dept the porter will request a signature from an appropriate member of staff. 2. The delivery will be handed to the member of staff signing for the delivery 3. The member of staff will immediately undo the delivery and place the vaccine(s) in the appropriate refrigerator. Vaccines left out of the Fridge or Fridge malfunction 1. Determine if the vaccines are still suitable for use, whether they can be returned to the fridge and whether the expiry date of the product needs to be amended. 2. If stability of the vaccine is not available via this website searching under the drug name, or contact Pharmacy Medicines Information on Ext If it is outside of normal working hours, please continue to quarantine the stock and contact Pharmacy during normal working hours ( Mon Fri). 3. Replacement stock can be ordered via Pharmacy Stores Order Line on Ext Pharmacy Operational manager Page 12 of 21

13 Appendix 2 The Assembly and Delivery of GP and School Health Vaccines SOP Title: The Assembly and Delivery of GP and School Health Vaccines Executive Summary: To ensure the cold chain is maintained whilst assembling and delivering vaccines to the school health programmes. Supersedes: 0.4 Description of Amendment(s): Amended according to good distribution practice This SOP will impact on: Pharmacy technicians and assistant technical officers working within the pharmacy dept. Financial Implications: Efficient handling of vaccines will reduce wastage. Procedural area: Stores & Distribution Document Reference: SD 002 Version Number: 0.5 Effective Date: 01 JUNE 2016 Author: CONSULTATION Committees / Group/Job title Senior Technician Purchasing and Distribution WDL- Approved by responsible person Senr. Management Team Other (please specify) APPROVAL Review Date: 01 JUNE 2018 Date Pharmacy Operational manager Page 13 of 21

14 SOP Locations: Copies of this SOP are stored in (tick in relevant box): Dispensary Technical Services Administration Clinical check General office Purchasing office bench (Master copy) Aseptic services Distribution area On call file Main dispensing Repackaging unit area office On call CD-ROM Secure Room Repackaging unit rooms Master induction file Medicines information Overview This SOP is concerned with: assembling and delivering vaccines for school health programmes, ensuring the cold chain is maintained at all times. Reference to other Operating Procedures Downloading the Comark Refrigerator Data Logger General storage/handling All vaccines must be kept between 2 C and 8 C, the cold chain must be maintained at all times. Daily monitoring of refrigerators ensures that the storage temperatures are within these limits. Vaccines are obtained from Movianto in refrigerated vehicles. On receipt, a vaccine order must be checked and stored immediately. Qualified equipment should be used to ensure correct transport conditions at all times. Pharmacy Operational manager Page 14 of 21

15 Assembly and Delivery of School Health Vaccines 1. Vaccines are issued to the school health cost centre 2. The designated transport company will collect deliveries for School Health (For schools within Eastern Cheshire the school nurse may collect the vaccines) School Health co-ordinators will request the vaccines as detailed on the vaccine schedule The vaccine will then be placed in a vaccine bag which are stored within the cold store as described; Large Bag- Full 2 cold gel packs Bubble wrap Required vaccines Data Logger Bubble wrap 2 cold gel packs Copy of bag label detailing the school name and type of clinic to be delivered to, delivery date and number of vaccines Medium Bag- Full 1 cold gel pack Bubble wrap Required Vaccines Data logger Bubble wrap 1 cold gel pack Copy of bag label detailing the school name and type of clinic to be delivered to, delivery date and number of vaccines If the required number of vaccine in the medium bag is very low then the amount of gel packs will require adjusting. For school health vaccines within Eastern Cheshire ensure that a BNF and two anaphylaxis boxes are supplied in a separate orange bag. For schools in Western Cheshire the vaccine is delivered to clinics in the area the day before the session. (Each clinic will require 2 anaphylaxis boxes which will be supplied on the first delivery to that clinic and then kept at the clinic until the end of the campaign). Ensure the driver signs the consignment note and give the bag(s) to the driver. Complete the vaccine tracking sheet for each delivery. Ensure that if bags are going to Eastern Cheshire a data logger is placed in a bag going to each area. This is to monitor the temperature of the vaccine journey. Returned Vaccines 1. No vaccines are able to be returned to stock for re-use from school nurse supplies. Pharmacy Operational manager Page 15 of 21

16 Appendix 3 Refrigerator Temperature Record Chart Ward / department: The temperature should be between +2 C and +8 C. Check daily. If the temperature is outside the recommended range, take appropriate action as indicated in the written procedure. Date 01/ /20 02/ /20 03/ /20 04/ /20 05/ /20 06/ /20 07/ /20 08/ /20 09/ /20 10/ /20 11/ /20 12/ /20 13/ /20 14/ /20 15/ /20 16/ /20 17/ /20 18/ /20 19/ /20 20/ /20 21/ /20 22/ /20 23/ /20 24/ /20 25/ /20 26/ /20 27/ /20 28/ /20 29/ /20 30/ /20 31/ /20 Current temperature Minimum temperature Maximum temperature Checked by (signature) Thermometer reset (tick) Comments Pharmacy Operational manager Page 16 of 21

17 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. E.g. 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? Vaccine Cold Storage Policy Details of person responsible for completing the assessment: Name: Karen Burton Position: Pharmacy Operational Manager Team/service: Pharmacy Department 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) The handling and storage of vaccines on wards and in clinical areas, in line with the Trusts Safe & Secure Handling of Medicines Policy and NPSA alert Vaccine Cold Storage 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 All Trust staff dealing with the storage and transport of vaccines All community based staff receiving vaccines from Pharmacy. 2.1 Give details of RELEVANT information available that gives you an understanding of who will be affected by this document Pharmacy Operational manager Page 17 of 21

18 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. 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 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 Pharmacy Operational manager Page 18 of 21

19 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 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?) No 2.3 Does the information gathered from indicate any negative impact as a result of this document? No 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 Explain your response: All staff employed by the Trust who would be using the medicine storage devices are competent in English language. If someone was having any difficulty understanding the requirements of the policy translation could be arranged in accordance with the trust interpreting 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 Explain your response: There is no differential impact due to gender - all staff required to use the medicine storage devices will need to adhere to this policy Pharmacy Operational manager Page 19 of 21

20 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 All staff required to use the medicine storage devices will need to adhere to this policy. If a member of staff has a visual impairment the policy could be provided in large print. If a member of staff is disabled or becomes disabled, then a risk assessment would be undertaken if there was any doubt about them safely being able to use the devices.explain your response: 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 Explain your response: There is no differential impact due to age - all staff required to use the medicine storage devices will need to adhere to this policy 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 Explain your response: There is no differential impact due to sexual orientation - all staff required to use the medicine storage devices will need to adhere to this policy. 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 Explain your response: There is no differential impact due to religion/belief - all staff required to use the medicine storage devices will need to adhere to this policy. 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 Explain your response: This policy relates to staff only 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 All staff using the medicine storage devices must adhere to this policy. Explain your response: Pharmacy Operational manager Page 20 of 21

21 4. Safeguarding Assessment - CHILDREN a. Is there a direct or indirect impact upon children? Yes No X 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: c. This policy relates to staff only and the use of vaccines If no please describe why there is considered to be no impact / significant impact on children 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? No compliance required as per NPSA requirements 6. Date completed: 23 rd March 2017 Review Date: 23 rd March 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? Actio 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: Pharmacy Operational manager Page 21 of 21