Community Pharmacy Enhanced Service Community Pharmacy Enhanced Service Service Specification For provision of Sharps Waste Collection Service Version 3 Effective from: October 2008 To October 2010 Review date August 2010 Version 3 Page 1 of 18 October 2008 Review 2010
Community Pharmacy Enhanced Service Contents Introduction 3 Nature of the service to be provided 3 Service Aims 3 Access to the service 3 Terms of the Service 3 Commencement and duration 3 Training and health and safety 3 Service description 4 Service funding 5 Payment mechanism 6 Service Activity 6 Record keeping 6 Target outcomes 6 Performance monitoring 6 Termination of the service 6 Confidentiality and Data Protection 7 Continuing professional development 7 Significant event reporting 7 Complaints 8 Professional Indemnity insurance 8 Equity and diversity 8 Health and safety 8 Signatures 9 Contacts and enquiries 10 Appendices 11 Version 3 Page 2 of 18 October 2008 Review 2010
Community Pharmacy Enhanced Service 1 INTRODUCTION This service specification defines the terms and standards required by Central and Eastern Cheshire and Western Cheshire Primary Care Trusts for the provision of a sharps waste collection service 2. Nature and Scope of Service to be provided Service Aims 2.1 To establish a sharps waste collection service via community pharmacies. 2.2 To maintain a quality professional service for patients. 2.3 To enable patients to dispose of prescribed sharps safely. 3. Access to the Service 3.1 Any patient / patient representative may present with waste sharps, presented in an approved and sealed sharps container, for disposal at any participating pharmacy. Terms of Service 4. Commencement and Duration The community pharmacy will provide the service strictly in accordance with the specification outlined below. The service specification will be signed by the participating pharmacy and will be subject to review every two years unless there is a need to do so before this time. A contract agreement will be signed by the community pharmacy contractor and will be subject to review at two years unless there is a need to do so before this time. The service should be provided for the total hours the pharmacy is open and for the duration of the contract agreement period between the contractor and the PCT 5. Training and Health and Safety 5.1 The community pharmacy providing this service must have written guidance and standard operating procedures which cover the specific health and safety risks associated with the service. Including the action to be taken in the case of needle stick injury Summary Points Minimise risk, Ensure prompt first aid and risk assessment, Commence prophylaxis as required, Seek professional advice and support The pharmacy s Standard Operating Procedure should be reviewed annually Version 3 Page 3 of 18 October 2008 Review 2010
Community Pharmacy Enhanced Service and the review documented. See appendix 2 for guidance: 5.2 The community pharmacy must have a standard operating procedure which specifically details the overall delivery of this Sharps service. The procedure should be reviewed annually and the review documented. See appendix 3 for guidance 5.3 All staff must be trained to follow the service delivery and health and safety standard operating procedures. 5.4 A staff training log which deals specifically with this service must be maintained and shown to the PCT on request. The training log must be updated annually to reflect the review of standard operating procedures. 5.5 Staff must not provide the service until trained. 5.6 Hepatitis B Vaccine Although the risk of needle stick injury is very low, staff who operate the service should be encouraged to have a Hepatitis B vaccine. see appendix 2 for more information on hepatitis B vaccine 5.7 Hepatitis B vaccine should be obtained and administered at the GP surgery. 5.8 Staff should inform the GP that the vaccine is required for occupational risk and therefore no charge (other than a standard prescription fee) should be incurred. 5.9 Staff should be aware of the procedure to be followed for a needle stick injury. This information must form part of your SOP. 6. Service Description 6.1 The community pharmacy will accept sharps for disposal, from all patients / patient representatives who present with them in an approved and sealed sharps container. 6.2 It is the responsibility of the patient to obtain a one way sharps container on prescription from their GP and to ensure that the sharps are safely sealed in this before presenting it to the community pharmacy for disposal. ( It is recommended that participating pharmacies obtain information posters and leaflets free from Daniels )See appendix 2 6.3 Before accepting such sharps for disposal, the community pharmacy staff will make a visual check of the returned sharps container to establish that it is sealed and safe to accept. 6.4 The pharmacy will not accept returned sharps in any container other than an approved sharps container supplied on prescription. 6.5 The community pharmacy staff will place (store) the returned, sealed sharps containers into a final container such as a cardboard box, used solely for the purpose of segregating sharps from this service Version 3 Page 4 of 18 October 2008 Review 2010
Community Pharmacy Enhanced Service 6.6 The cardboard box (final container) will be collected by the waste carrier, Intercare, on a monthly basis (together with other DOOP bins containing unused and unwanted patient returns ) 6.7 It is not appropriate to use a yellow bag as a final container. The Intercare driver is required to count the number of individual Daniels sharps containers collected from pharmacies: For health and safety reasons they should not be retrieving containers from an enclosed vessel such as a bag. 6.8 Sharps from this service must not be placed into a container with sharps from a Syringe and Needle Exchange Scheme. 6.9 Staff may EITHER, accept the returned sharps container and (using the handle on the returned container) place it in the final waste collection container themselves OR the patient (or patient s representative) may be escorted to the final waste collection container (or the container brought to them) and asked to place their sharps container into it themselves. See flow chart page 6 The community pharmacy will ensure that sharps waste is collected according to the waste carrier s schedule. 6.10 The PCT is responsible for the contract with the waste disposal company. 6.11 Community pharmacy service providers may display material posters etc to advertise the service. 6.12 Community pharmacy service providers will prominently display any material, e.g. posters, provided by the PCT to support service delivery if requested. 6.13 Whilst the service specification does not require pharmacy staff to offer related advice to their customers e.g. infection control, waste management issues, they are free to do so if they wish. 7. Service Funding 7.1 Community pharmacies providing a sharps waste collection service will be reimbursed at 200 per year, irrespective of the amount of sharps collected. The fee will be paid as a lump sum on receipt of an annual declaration from service providers of intent to continue the service from the named community pharmacy. 7.2 The PCT will reimburse prescription costs on production of a receipt, for staff that have the Hepatitis B Vaccine and pay for their prescription. 8. Data Collection 8.1 The community pharmacy will maintain and retain copies of the official documentation required by the waste carrier and will show evidence of this to the PCT if requested. 9 Payment Mechanism 9.1 Service funding will be paid by BACS through the Cheshire Health Agency. Version 3 Page 5 of 18 October 2008 Review 2010
Community Pharmacy Enhanced Service 10. Record Keeping 10.1 The community pharmacy will maintain and retain copies of the official documentation required by the waste carrier and will show evidence of this to the PCT if requested. 10.2 The community pharmacy will maintain training records and will show evidence of this to the PCT if requested. 10.3 The agreement does not require pharmacies to keep records of patient returns. 11. Service Activity 11.1 It is the responsibility of the participating pharmacy to have a process in place which ensures that all new staff, are aware of all enhanced services provided by the pharmacy and commissioned by the PCT and must maintain continuity of service during and after staff changes. 11.2 If this commissioned service cannot be provided under the terms of this agreement, for whatever reason the pharmacy must contact the PCTs Contracts Officer. (see contacts and enquiries) 12 Target Outcomes 12.1 Not applicable for this service. 13. Performance Monitoring 13.1 The pharmacy must fully comply with the National Pharmacy Contract regulations for delivery of Essential Services before they can provide enhanced services. The PCT retains the right to audit any part of the service to ensure continued quality. 13.2 The PCT reserves the right to ask for evidence from the Pharmacy that it is following the procedures outlined in this specification. 13.3 The pharmacy will co-operate with any PCT led assessment of service user experience or audit of the service. 13.4 Changes to the level or quality of the service will not be introduced without prior agreement with the PCT. Changes will be authorized in writing. 14. Termination of the Service 14.1 Central and Eastern Cheshire and Western Cheshire PCT reserves the right to stop the service in one or all of its pharmacies with immediate effect if: a pharmacy/pharmacist fails to comply with the service specification there are prolonged periods of time where the pharmacy is unable to provide the service the individual pharmacist and / or contractor acts outside the ethical governance framework for the profession, brings the profession into Version 3 Page 6 of 18 October 2008 Review 2010
Community Pharmacy Enhanced Service disrepute, or is subject to an NHS or professional disciplinary process. 14.2 Either party may terminate this agreement by providing written notice of their intention to do so. A period of one month should be given as notice. 14.3 Where the community pharmacy contractor gives notice to terminate the service the contractor must continue to provide a full service during the notice period. 15. Confidentiality and Data Protection 15.1 The pharmacy will provide a nonjudgmental patient centered confidential service. The pharmacist must not disclose to any person other than authorised by CECPCT, any information acquired by them in connection with the provision of the service which concerns. The CECPCT, its staff or procedures The identity of any service user The medical condition or any treatment received by any service user 15.2 Pharmacists may need to share relevant information with other health care Professionals and agencies, in line with locally determined confidentiality arrangements, including, where appropriate, the need for the permission of the patient to share the information. 15.3 The pharmacy must protect personal data in accordance with provisions and principles of the Data Protection Act. 15.4 The pharmacist must ensure that all their staff conform to the NHS Code of Practice on Confidentiality and data protection and ensure that all staff involved with the service are appropriately trained. 16. Continuing Professional Development 16.1 Where there are concerns regarding poor performance in the delivery of this service these will be addressed separately as a clinical governance matter. 17. Significant Event Reporting 17.1 The pharmacy must have an adverse incident and near miss reporting system in place which includes maintaining a log of patient safety incidents. The pharmacy should be able to demonstrate that it has learnt from an event. 17.2 ALL (Patient or staff) safety incidents directly linked to this service must be reported to the appropriate PCT in writing. For Central and Eastern Cheshire PCT - Medicines Management Enhanced Service Co-ordinator For Western Cheshire PCT - Contracts Officer (Lee Davies) Version 3 Page 7 of 18 October 2008 Review 2010
Community Pharmacy Enhanced Service (see Contacts and Enquiries page 10) 18. Complaints 18.1 The pharmacy must have a complaints procedure that complies with national standards. Complaints directly linked to this service must be reported to the PCT who reserve the right of directly investigating any complaints about the service. 18.2 Feedback both positive and negative should be forwarded to the PCT Enhanced Service Co-ordinator so that action can be taken to amend the service as necessary. 19. Professional Indemnity Insurance 19.1 It is the responsibility of the contractor / pharmacist to maintain insurance in respect of public liability and personal indemnity against any claims whatsoever which may arise out of the terms, conditions and obligations of this Agreement. 20. Equity and Diversity 20.1 The pharmacist/pharmacy staff must comply with requirements of the Race Relations Act of 1976 and the Race Relations (Amendment) Act 2000, and will not treat one group of people less favourably than others because of their colour, race, culture, religion, gender, nationality, age, marital status, sexual orientation, disability or ethnic origin. It is the responsibility of the pharmacist to audit the needs of the population they serve and amend the service along with support from the PCT. E.g. leaflets in other languages. 21. Health and Safety 21.1 The community pharmacy shall comply with the requirements of the Health and Safety at Work Act 1974, the management of health and safety at work regulations 1999 and any other acts, regulation, orders or rules of law pertaining to health and safety. 22. Freedom of Information 22.1 Both parties recognize that this service specification and/or associated recorded information in respect of the one to one stop smoking service may be subject to FOI requests. Each party shall comply with any such FOI requests received, in accordance with the Freedom of Information Act 2000 legal obligations. The PCT will advise if required 22. Signatures 22.1 Pharmacies providing the service must have their names on an enhanced service provider list held at the PCT. Version 3 Page 8 of 18 October 2008 Review 2010
Community Pharmacy Enhanced Service Signatures Agreement to provide a Waste Sharps Collection Service under the terms outlined in this service specification from the pharmacy specified below Pharmacy Full Address Signed Print Position A copy of this agreement to be held in the participating pharmacy A copy of this page to be returned to: Lee Davies 1829 Building Countess of Chester Health Park Liverpool Road Chester CH2 1UL Version 3 Page 9 of 18 October 2008 Review 2010
Contacts and Enquiries Community Pharmacy Enhanced Service CECPCT Medicines Management Enhanced Service Co-ordinator Universal House ERF Way (off Pochin Way) Middlewich Cheshire CW10 0QJ Tel 01606 544668 Email kathy.smith@cecpct.nhs.uk Service Issues, E.g. Waste collection failure Carol Quayle Chester Health Agency 01244 650 402 Marilyn Knass CECPCT Medicines Management Project Facilitator Universal House ERF Way (off Pochin Way) Middlewich Cheshire CW10 0QJ Tel: 07825844832 Email: marilyn.knass@cecpct.nhs.uk Western Cheshire PCT Contracts Officer Lee Davies 1829 Building Countess of Chester Health Park Liverpool Road Chester CH2 1UL Tel 01244 6504 Email lee.davies@wcheshirepct.nhs.uk Version 3 Page 10 of 18 October 2008 Review 2010
Community Pharmacy Enhanced Service Specification Sharps collection service Appendix 1 marilynknass Version 3 October 2008 Review date August 2010 Page 11 of 18
Community Pharmacy Enhanced Service Specification Sharps collection service Appendix 1 marilynknass Version 3 October 2008 Review date August 2010 Page 12 of 18
Appendix 2 Community Pharmacy Enhanced Service Specification Sharps collection service Accidental Exposure to Blood or Body Fluids Extract from Infection Control Nurses Association Guidance for General Practice Risk Assessment This document aims to assist employers to assess the risk of infection from blood borne viruses (BBV) such as hepatitis B and C or HIV within the workplace and to decide what measures are required to control this risk, as in vaccination and / education programmes. The Control of Substances Hazardous to Health (COSHH) (1999) Regulations requires all employers to make their own risk assessments and to implement measures to protect employees. The Health Service Circular (HSC) 2000/020 requests Primary care Organisations (PCO) and all independent contractors, to ensure arrangements are in place to manage accidental incidents that result in exposure to BBV. If exposure occurs, always contact your line manager and one or more of the following: Your GP Your Local infection control nurse For the East: Anita Swain 01625 661417 For Central: Rita Huyton 01606 564 091 Consultant in Public Health For the East: 01625 508 300 For Central: 01270 415300 Body Fluids that may pose a risk of BBV transmission if significant occupational exposure occurs include: Amniotic fluid Cerebrospinal fluid Human breast milk Pericardial fluid Pleural fluid Exudates or other tissue fluid from burns or other skin lesions Saliva in association with dentistry(likely to be contaminated with blood) Synovial fluid Unfixed human tissues and organs Any other body fluid, if visibly blood stained Types of Exposure Accidental exposure to body fluids cans occur by: percutaneous injury (e.g from needles, instruments, bone fragments, significant bites that break the skin) exposure of broken skin (e.g abrasions, cuts, eczema) exposure of mucous membranes, including eyes and mouth marilynknass Version 3 October 2008 Review date August 2010 Page 13 of 18
Community Pharmacy Enhanced Service Specification Sharps collection service Post-exposure Management Figure 1 indicates the action staff must take following an inoculation accident or accidental exposure to blood or body fluids. (This can be photocopied and displayed in the workplace) An integrated approach to post-exposure management that incorporates HIV, hepatitis B and hepatitis C is recommended by the Chief Medical Officers Expert Advisory Group on AIDS (EAGA) and the subsequent EAGA guidance HIV Post-Exposure Prophylaxis (PEP) According to the EAGA, occupational exposure to air borne viruses is unnecessarily common. Many exposures result from staff failing to follow recommended procedures. Although preventing inoculation injury (or any other route of exposure) is the primary means of preventing occupationally acquired BBV, appropriate post-exposure management is an important element of workplace safety. IMMEDIATE ACTION STOP WHAT YOU ARE DOING AND ATTEND TO THE INJURY Encourage bleeding of the would by applying gentle pressure Do not suck Wash under running water Dry and apply a waterproof dressing If body fluids splash into If body fluids splash into eyes irrigate with cold water mouth, do not swallow, rinse out several times with cold water Report the incident to your manager Contact GP local control of infection nurse etc. Complete accident form Initiate investigation as to the cause of the incident and risk assessment Injury from clean/unused instrument or needle = no further action. Injury from used needle or instrument Risk assessment in conjunction with microbiologist, infection control doctor or consultant for communicable disease control. Fig 1 marilynknass Version 3 October 2008 Review date August 2010 Page 14 of 18
Community Pharmacy Enhanced Service Specification Sharps collection service Minimising the Risk To minimise the risk of transmission of BBVs from infected patients to health care workers, and from infected healthcare workers to patients, all staff should be informed and educated about: the possible risks and avoidance of occupational exposure immediate first-aid procedures, should such an event occur action following first-aid procedures the importance of seeking urgent advice the importance of reporting all occupational exposures and that everyone knows whom to report to the application of good basic hygiene practice, including regular hand washing covering existing wounds, skin lesions and all breaks in exposed skin with waterproof dressings or with gloves if hands are extensively affected. Using protective clothing as appropriate, including protection of the mucus membranes of the eyes, mouth and nose from blood or body fluid splashes Avoiding wearing open footwear in situations where blood may be spilt, or where sharp instruments or needles are handled In addition your policy should address the following points: Designate one or more persons who you may urgently refer exposed persons to for advice i.e CCDC, local infection control nurse. Where the source patient is known, refer them to an appropriate doctor for professional support and blood testing, subject to consent, serum will be tested for hepatitis B and C and HIV Provide clear channels for access to HIV PEP and hepatitis B immunoprophylaxis and professional support following hepatitis C exposure. Encourage workers predominantly at risk to consider before an event, whether they would wish to take PEP. A clear audit trail of any untoward event is obligatory to demonstrate a well-planned and timely pathway. Initiate investigation as to cause of incident and risk assessment. Management of HIV Risk The Chief Medical Officers Expert Advisory Group on ASIDS recommends that antiretroviral PEP for HIV should be considered if there has been exposure to blood or other high risk body fluids or tissue known to be strongly suspected to be, infected with HIV. Therefore policies should be developed, implemented and monitored to ensure a clear pathway directing all healthcare personnel to timely PEP, such a scheme requires co-operation between all key organisations, as well as an understanding of the managers responsibility to make adequate [f as it details of the exposure or injury to the healthcare worker possible pregnancy of the individual. However pregnancy does not preclude the use of PEP. There has been no indication of particular problems for babies of HIV infected women who have become pregnant whilst already receiving antiretroviral medication access to antiretroviral drugs within an hour of injury Clinical information about the source patient in terms of HIV diagnosis, treatment, and the stage of infection. marilynknass Version 3 October 2008 Review date August 2010 Page 15 of 18
Community Pharmacy Enhanced Service Specification Sharps collection service Timing and Duration of PEP PEP is ideally given within an hour of exposure, and the full course lasts for 4 weeks. If PEP is delayed for any reason and the risk is very high (E>G> the source person later proves to be HIV positive) it is still worth considering PEP even if it is as long as 2 weeks after the incident. An injured worker may decide to take PEP drugs for a short period until the results of the source person (if they have consented) are known, or following discussions with a medical specialist. Management of Hepatitis B (HBV) risk The hepatitis B virus is second only to tobacco among cancer causing substances. There ate up to 500million people in the world carrying the hepatitis B virus. However, the United Kingdom has a low prevalence when ranked against some other countries. Despite this, because of its severity, hepatitis B is still considered to be one of the most serious infections in the country. The risk of contracting HBV from needle stick exposure in a healthcare setting is much higher than HIV, both because of the greater infectivity of the virus and the greater prevalence of HBV in the community. Just 0.00004 ml (0.4 micro litres) of infected blood can transfer infections to humans. Researchers estimate that approximately 20% of healthcare workers who have not been vaccinated for hepatitis B who are exposed to blood from hepatitis B e antigen (HBeAG) positive patients will become infected. New guidance for staff carrying out exposure prone procedures (EPPs) who are HBsAG positive requires that they must have their viral load measured periodically. Marker full name indicated HBsAG hepatitis B surface carrier or current infection antigen HBeAG hepatitis B antigen current infection/highly infectious/chronic carrier Anti HBsAG antibody to HBsAG previous infection/immunisation/immunity Anti HbeAG (anti-hbe) antibody to HBeAG hepatitis B surface antigen carrier with low risk of infection Anti-HBc Antibody to hepatitis B core antigen persons who have had hepatitis B infection in the pastor have acute infection. It is not induced by immunisation igm Anti-HBc igm antibody to acute or recent hepatitis B hepatitis B core antigen infection Hepatitis B virus DNA virus DNA viral replication and high infectivity marilynknass Version 3 October 2008 Review date August 2010 Page 16 of 18
Community Pharmacy Enhanced Service Specification Sharps collection service Management of Hepatitis C (HCV) Risk No effective prophylaxis to hepatitis c currently exists. Therefore appropriate professional support is important and should be available to the injured person. Infection control precautions recommended for all BBV apply Vaccination It is recommended that all healthcare workers who have direct contact with blood, blood stained body fluids, or patient s tissues, particularly those carrying out EPPs should be vaccinated should be vaccinated against hepatitis B virus (HBV). Immunological response to vaccine should be checked. Those staff failing to respond should be further immunised. Consent should also be obtained for further testing to distinguish non-responders from those who are HIV carriers. The primary course consists of three injections normally at 0,1 and 6 months. More rapid courses consist of either 3 injections at monthly intervals and a booster at 12 months, or injections at 0, 7 and 21 days followed by a booster at 12 months. Antibodies can be checked at 4 weeks after course completion, to determine whether or not there has been a response. Vaccine Response Rates Vaccine response rates are generally 95% in young adults, children and newborn babies, but may only reach 80% in older men. Immunity is known to decrease with age, especially in those over 40 years of age, but what is not known is whether or not boosters are necessary for babies and children to provide lifelong immunity. Nor is it precisely known how long the response to the vaccine will persist, which remains variable and dependant on levels of anti-hbs and course completion. Such variations have made it impossible to define a minimum protective level of anti HBs Low or non-responders need to be informed that they may not be protected and should seek passive immunisation, as soon as possible and preferably within 48hours with HBV specific immunoglobulin if they suffer accidental exposure. Others who have been successfully immunised should receive a booster injection, unless definitely known to have adequate protective anti-nhs levels. Immunoglobulin Note that if an immunoglobulin is required following exposre, it could adversely influence sero-conversion of any live vaccine given within the following three months. If a live vaccine was administered three weeks before the immunoglobulin, this may also be affected. Summary Points Minimise risk Ensure prompt first aid and risk assessment Commence prophylaxis as required Seek professional advice and support marilynknass Version 3 October 2008 Review date August 2010 Page 17 of 18
Appendix 3 Community Pharmacy Enhanced Service Specification Sharps collection service PROCEDURE FOR PHARMACY STAFF RECEIVING PRESCRIPTION SHARPS CONTAINERS FOR DISPOSAL Person arrives at Pharmacy with Sharps in a container. Is it a prescription Sharps bin? yes NO Person arrives with sharps in another container: 1. Ask patient to return to their GP to get a Sharps bin on a prescription. You may wish to give them a Sharps bin card 2. Tell patient to transfer their needles, at home, into the correct Sharps bin (once their prescription has been dispensed) and 3. Return full, locked Sharps bin to Pharmacy for disposal. Ask Person to show you that the container lid is firmly on And is it LOCKED? YES No Ask person to correctly lock the container. Instructions are on the Sharps bin card. When you are satisfied that the lid is firmly locked yes Either: Direct / escort person to the collection bin and ask person to place container in it. Or Staff accepts container and using the handle on the sharps container place in collection bin X Remove any patient identifying information before placing the returned container into your final container (for collection by the waste carrier) marilynknass Version 3 October 2008 Review date August 2010 Page 18 of 18