Specialised, Enhanced Sexual Health Service (Community Pharmacy) Incorporating Emergency Hormonal contraception (EHC), Chlamydia screening, treatment, partner notification, clinic referral and initiation of long acting reversible contraception (LARC) to women Aged 13 to 19 years Service Level Agreement 1. Parties to the Agreement for This agreement is between: …………………………………………………………… (“The Pharmacy”) and NHS North of Tyne (“The Trust”) for the provision of specialised enhanced sexual health services by the following named authorised pharmacists: 1.………………………………………………………. (RPSGB Reg. No………………) 2……………………………………………………….. (RPSGB Reg. No………………) 3……………………………………………………….. (RPSGB Reg. No………………) 4……………………………………………………….. (RPSGB Reg. No………………) 2. Aims and intended service outcomes The purpose of this specialised, enhanced sexual health service is to ensure equitable and timely access to a comprehensive range of sexual health services for clients aged 19 years and under who are sexually active delivered in community pharmacies. The cost of buying emergency hormonal contraception (EHC), approximately £25 per course, excludes many clients from accessing EHC via the community pharmacy. The product licence for over the counter sale further restricts access of this target group, as sales are restricted to those 16 years of age or over. This service will contribute to a reduction in the number of unplanned pregnancies and terminations, amongst teenagers, in line with public health targets by reducing the barriers to access EHC, and provide a platform to discuss future methods of contraception by direct referral to the local Sexual Health Clinic or timely initiation of implantable or injectable long acting reversible contraception (LARC) as appropriate. The service and related training will support experienced community pharmacists, in designated pharmacies work towards the Access Standards contained in the Department of Health’s “You’re welcome” criteria. Page 1 of 27 3. Scope of service to be provided 3.1 Women, hereafter referred to as clients, may self refer, or be referred for assessment by other professionals. 3.2 All clients requesting EHC from the pharmacists must be informed of the free scheme. 3.3 Clients may attend solely to request initiation of LARC and/or for Chlamydia screening and treatment. 3.4 The pharmacist will provide advice and guidance to the client as well as assessing their suitability for EHC and follow on LARC. This will be according to the Patient Group Direction (PGD), see appendices 3 and 4. The pharmacist undertaking the specialised enhanced sexual health service will: Undertake a comprehensive sexual health history and practice, and risk assessment. Provide EHC as appropriate Provide verbal and written information about all future contraceptive options to inform choice about future choices. Give information on safer sex practices and provision of information on C-Card Condom Distribution Scheme. Increase uptake of opportunistic Chlamydia screening for 19 years and under in line with the aims of the National Chlamydia Screening Programme (NCSP) by provision of testing kit. At the initial consultation every woman will be counselled about sexually transmitted infections (STIs) and the NCSP. They must be provided with a Chlamydia testing kit and advised they may be asked to return to the pharmacy for treatment and initiation of the partner notification system if found to be positive. If requested by Chlamydia Screening Central Office treat clients with a positive test result and initiate partner notification (PN) for follow up by NCSP. See appendix IX for care pathway. Provide verbal and written information on effectiveness, duration of use, side effects and those symptoms that require urgent assessment to increase client understanding. Fitting, monitoring, and checking of contraceptive implants licensed for use in the UK, as appropriate. Injection of Depo-Provera® and bi-monthly follow-on injections as appropriate. Production of an up-to-date register of clients fitted with a contraceptive implant and depot injection, to be used for audit purposes. Provision of adequate equipment. Certain special equipment is required for implant fitting. This includes an appropriate room fitted with a chair and with adequate space, the provision of sterile or disposable surgical instruments and other consumables, equipment for resuscitation, and facility for local anaesthesia provision. This specification includes the provision of sterile or disposable surgical instruments and other consumables. Page 2 of 27 Ensure arrangements in place to review clients experiencing problems with LARC in a timely fashion and the practice able to appropriately manage nuisance side-effects. Ensure the client understands the need for the implant to be removed or replaced within three years, or the need for bi-monthly follow up injections of depot injection as appropriate. Production of an appropriate clinical record. Adequate recording should be made regarding the client’s clinical, reproductive and sexual history, the counselling process, the results of any STI screening, problems with insertion, the type and batch number of the implant and expiry date of the device. Any follow up consultations should be documented. An annual audit of the register of clients fitted with a contraceptive implant; reasons for removal; length of continuation; complications or significant events should be undertaken and sent to the Clinical Lead for Contraception and Sexual Health in the PCT. Each woman must be offered the opportunity to be referred directly to their nearest Sexual Health Clinic at all stages of the consultation for STI or contraceptive advice or where there are contra-indications, see appendix 2 for referral information and documentation. Chlamydia treatment can be provided to anyone with a positive Chlamydia screening test result who has requested their treatment to be provided by a participating community pharmacy. 3.5 Data will be collected on the record form provided which should be submitted along with the claim form on a monthly basis. 3.6 In addition the pharmacist will ensure that clients are given details of local services for future use, e.g. Contraception and Sexual Health Clinics (CaSH), and Genito-urinary (GUM) services. This should also include a brief description of what each service provides and leaflets as well as information on effective condom use a pack of condoms and information on where to obtain condoms via the C-card & Chlamydia Screening and treatment schemes. Where client consent is obtained complete and submit contraceptive referral proforma for those clients declining LARC from the community pharmacist 4. Service restriction 4.1 This agreement is strictly limited to specifically trained specialised pharmacists within specific pharmacies identified by The Trust. The pharmacists must have completed the approved training course and supportive training material, undertaken mandatory Cardio-Pulmonary Resuscitation & Anaphylaxis within the previous 12 months hold an honorary contract with Northumberland Care Trust, have had a CRB check within the previous three years and have been recognised as competent to undertake LARC insertion and administration by an RCN approved trainer. Page 3 of 27 5. Clinical Governance 5.1 5.2 The pharmacy has a duty to ensure that pharmacists involved in the provision of the service have relevant knowledge and are appropriately trained and competent in the operation of the service. Practitioners should be familiar with the NICE guidance on long acting reversible contraception and should be working in compliance with this guidance at all times. Specifically, clinicians should be competent in resuscitation, demonstrate a continuing sustained level of activity (at least 6 insertion and 6 injections procedures per year), conduct regular audits and take part in necessary supportive educational activities, including an annual update session The pharmacist involved in the provision of the service must be aware of and operate within local protocols concerning local anaesthetic use, decontamination procedures and handling of clinical waste. The pharmacy must have infection control policies that are compliant with national guidelines including the handling of used instruments, excised specimens and the disposal of clinical waste. 5.3 The pharmacy must maintain appropriate records to ensure effective ongoing service delivery, clinical audit and reporting of activity and billing. 5.4 The named pharmacist(s) will: Assess clients for suitability of treatment at the time of presentation. Obtain and record informed consent for treatment from the client consistent with Department of Health guidance. Provide advice to the client on post-operative care and pain relief. Provide any necessary post-operative follow-up, as required. 5.5 The Trust will alert all practitioners providing this service to any urgent incidents or contraindications relating to implants. 5.6 Confidential records of consultations and competence assessment according to The Fraser guidelines must be securely retained for three years and nine months. 6. Quality Indicators 6.1 6.2 6.3 6.4 6.5 6.6 The pharmacy will provide a mutually convenient time for implant insertion or depot injection and Chlamydia treatment. The pharmacy reviews its standard operating procedures and the referral pathways for the service on an annual basis. The pharmacist can demonstrate they have undertaken CPD relevant to this service. The pharmacy participates in an annual PCO organised audit of service provision. The pharmacy conforms to the Decontamination Guidance provided by the PCT. The pharmacy co-operates with any locally agreed PCT-led assessment of service user experience. Page 4 of 27 6.7 The pharmacy records and investigates any clinical incidents or complaints, according to the guidance provided by the PCT and provide a written summary to the Clinical Governance manager at the PCT. The pharmacy maintains a register of the clients accessing the service being screened and treated for Chlamydia. The Pharmacy takes account of the Department of Health You’re Welcome Standards 6.8 6.9 6. Clinical exclusions 6.1 7. Clinical exclusions to EHC or LARC are outlined in respective Patient Group Direction, but clients may prefer to seek advice from, or be referred to one of the North of Tyne Specialist sexual health services if clients have chronic medical conditions or disorders that cause concern. Agreement Period 7.1 The agreement will commence on dd/mm/2009 to dd/mm/20yy. 7.2 It will be subject to renewal if agreed by all parties and successful completion of an annual update at Carlton Street Clinic, evidence of attendance at the Northumberland Care Trust mandatory Cardio-Pulmonary Resuscitation & Anaphylaxis training workshop. 7.3 The agreement may be terminated, without penalty, if the Pharmacy or NHS North of Tyne gives the other party one-month notice in writing. 8. Obligations of the Pharmacy and the Trust 8.1 The Pharmacy must provide the service, delivered by the named pharmacists, in accordance with the Service specification. 8.2 The Trust will manage the scheme in accordance with the Service specification. 9. Terms and Fees 9.1 The pharmacy will be remunerated according to the fee rate set out below, 9.4, uplifted for inflation as agreed each year when the contract is reviewed. Payment will be made against a monthly claim submitted by the pharmacy and supporting detail as follows: Clients treated identified by : Age of client Postcode Date of treatment Details of consultation/treatment provided to each client Consultation/treatment provided by Previous form of contraception used Remuneration claimed. Numbers of clients being screened for and receiving treatment Chlamydia infection as part of the NCSP Page 5 of 27 9.2 The pharmacy will bear the costs of: Consumables used in providing the treatment Cleaning equipment and the treatment room Administration of the service Provision of necessary information to the PCT to audit the contract and settle invoices. Client transport costs will not be met by the pharmacy or the Primary Care Trust. 10.3 Payment will be paid monthly in arrears to the pharmacy on receipt of the completed relevant signed forms by BACS from NHS North of Tyne direct into the bank account of the pharmacy. The Community Pharmacy Record Audit should be completed and submitted to: Chelsea Harrison Medicine Management FAO NHS North of Tyne Bevan House 1 Esh Plaza Sir Bobby Robson Way Great Park Newcastle NE13 9BA Fax: 0191 217 2506 Description of relevant forms Form Number Form 1 LARC monthly audit sheet 2 Referral proforma for contraceptive support 3 Summary record of EHC consultations 4 5 6 7 8 9 Record of consultation for Plan B (POEC) (Levonelle 1500®) Assessing competence for clients according to Fraser guidelines Invoice for supply of Plan B (POEC) Record of consultation for long acting reversible contraception (LARC) – Implanon®/ DepoProvera® Northumberland, Tyne & Wear CSP Partner Notification Form Northumberland, Tyne & Wear CSP Pharmacy Treatment Sheet location To be submitted monthly to NHS North of Tyne Appendix I To be faxed to relevant Sexual Health Service as appropriate Appendix II To be submitted monthly to NHS North of Tyne Appendix III To be retained within the Pharmacy for 3 years Appendix IV To be retained within the Pharmacy for 3 years Appendix V To be submitted monthly to NHS North of Tyne Contained within each specific PCO Plan B SLA To be retained within the Pharmacy for 3 years Appendix VI To be faxed to NTWCSP Central office as appropriate Appendix VII To be faxed to NTWCSP Central office as appropriate and NHS North of Tyne Appendix VIII Page 6 of 27 10.4 Banking details Banking details Name of Bank Address: Sort Code Account Number 10.5 Fee structure Description Fee Plus drug cost (Drug Tariff + VAT) Plan B consultation fee £7.00 N/A 3 Supply of EHC £5.50 Yes 3&6 £4.50 N/A Payment made automatically monthly in arrears. £4.50 Yes 8&9 Yes 1 Yes 1 Yes 1 Receipt of Chlamydia screening test by Microbiology Department1 Chlamydia treatment and PN initiation (plus drug cost)2 Insertion of the Implanon® device (plus drug cost)2 Initiation of Depo-Provera® Follow up Depo-Provera® injection (2 monthly intervals) 10. 2 £60.00 £30.00 (plus drug cost)2 £7.00 (plus drug cost)2 Resolution of disputes 10.1 1 Form to be submitted to make claim It is expected that any disputes will be resolved between the pharmacy and the PCT. However, in the event that they cannot, the dispute will be referred to an arbiter that is acceptable to both parties. Each Community Pharmacy will have a unique ID number and returns received by Medicine Management (Commissioning) from the CSO will be used to determine payments Drug cost at tariff or list price as appropriate Page 7 of 27 11. Authorisation Name of Pharmacy Agreed on behalf of the Pharmacy Agreed on behalf of the NHS North of Tyne _ _/ _ _/ 200_ _ _/ _ _/ 200_ Name Position/Title Signature Date By signing this agreement the Pharmacy and those trained pharmacist(s) will comply with and work in accordance with the provisions of this SLA and the attached Service Specification. Name(s) of trained Pharmacist(s) RPSGB Registration number Date _ _/ _ _/ 200_ _ _/ _ _/ 200_ _ _/ _ _/ 200_ _ _/ _ _/ 200_ 12. Confidentiality 12.1 The Pharmacists and their staff must not disclose to any person other than a person authorised by the NHS North of Tyne any information acquired by them in connection with this Agreement. 12.2 Without prejudice to the generality of Clause 9.1, the Pharmacist and their staff must not disclose to any person other than a person authorised by the NHS North of Tyne any information acquired by them in connection with the provision of the services hereunder which concerns: The NHS North of Tyne, its staff or procedures The identity of any client The medical condition of or the treatment received by any client. Page 8 of 27 13 Eligibility 13.1 The pharmacy must employ one or more pharmacists or locum pharmacist who have completed the NHS North of Tyne training programme and authorised to undertake this specialised, enhanced sexual health service. 13.2 Authorisation is conditional on the following: Securing an honorary contract with Northumberland Care Trust Completion of the relevant CPPE training packs Annual attendance at the mandatory Northumberland Care Trust Cardio-pulmonary and Resuscitation training session Successful completion of the Carlton Street practical initial training and annual follow up training sessions Attendance at the evening theory training session Commitment to ensure continuous professional development pertaining to EHC and LARC, e.g. attendance at a local fitters forum or event Signing of the Service Level Agreement and EHC and LARC Patient Group Directions CRB check within previous three years 13.3 The pharmacist is authorised to undertake the duties outlined in this service level agreement in pharmacies registered as part of the scheme. Should the pharmacist leave the employ of the premise owner and not be replaced immediately by an accredited pharmacist, the Trust must be informed and the pharmacy will no longer participate in the scheme, unless there are other authorised pharmacists employed at the premises. The pharmacist may be able to continue to participate in the scheme at other authorised pharmacy premises in NHS North of Tyne only with the specific agreement of the Trust. 13.4 A copy of the protocol must be kept freely available in the pharmacy and all staff should be aware of its contents. If a locum is employed who is not authorised to provide the service, clients must be made aware of alternative locations where the service can be obtained. 13.5 To become authorised premises the pharmacy must have been identified by the Trust as being in an area with a high level of teenage pregnancies. The premises must have a consultation area. The consultation area must: Enable the pharmacist and client to sit down together Enable the conversation to be carried out at normal volume without being overhead Be clearly signed as a private consultation area Be suitable for the administration and removal of the LARC, with provision of suitable protective and cleaning materials 13.6 All serious clinical incidents must be reported to NCT using the appropriate clinical incident form. Page 9 of 27 13.7 14 15 Indemnity 14.1 The Pharmacy/pharmacist shall be liable for, and shall indemnify NHS North of Tyne, its officers, employees and agents against any liability, loss, claim or proceedings arising under statute or at common law in consequences of this Agreement. 14.2 The Pharmacy shall maintain insurance of a minimum of £5 million in respect of public liability and personal indemnity against any claims, whatsoever which may arise out of the terms and conditions and obligations of this Agreement and will at all times during the period of this Agreement be a member of a recognized professional organisation. The Trust will have the right to see documentary evidence of the foregoing including policy renewal receipts prior to commencement of this agreement or at any stage during the period of this Agreement. If the pharmacy fails to maintain adequate insurance, or is no longer a member of an appropriate professional organisation (for whatever reason), this Agreement may be terminated by the Trust without prejudice to any other rights and remedies available. Tax Liabilities 15.1 16 It is hereby declared that it is the intention of the parties that the Pharmacist/ Pharmacy shall have the status of a self-employed person and shall be responsible for all Income Tax, VAT liabilities, and National Insurance or similar contributions in respect of his fees and reimbursements. Termination of agreement 16.1 16.2 16.3 17 All pharmacists must have an up to date CRB Clearance which should be renewed every 3 years. (The Trust will fund and facilitate the clearance process). Either party can terminate this agreement by giving one months’ notice in writing, unless both parties agree a shorter period of notice. This Agreement may be terminated by either party as provided by Clause 16.1 provided always that NHS North of Tyne may terminate or suspend this Agreement forthwith if there are reasonable grounds for concern including, but not limited to, malpractice, negligence or fraud on the part of the pharmacy. If events occur which could not have been reasonably foreseen and are of such substance to affect the ability of either party to meet their obligations, then joint negotiations will be undertaken to consider the future provision of services or to terminate this Agreement without prejudice. Standard of Service 17.1 The services hereunder shall be provided in accordance with this Agreement and, except in emergencies, the pharmacy shall not deviate from this Page 10 of 27 agreement without the prior written consent of the NHS North of Tyne. 17.2 In addition to any more specific obligations imposed by the terms of this Agreement it shall be the duty of the pharmacy to provide the services hereunder to a standard, which is in all respects to the reasonable satisfaction of the NHS North of Tyne. The standard and quality of service will be of paramount importance to the NHS North of Tyne in managing this Agreement. 17.3 Without prejudice to the Contractors obligations to meet all performance requirements under the contract, the contractor must, in the provision of the service meet the standards set out in “Standards for Better Health” published by the Department of Health on 21 July & available on the DH website (gateway reference 3528). The contractor shall comply with all relevant legislation (and directions there under) and have regard to all relevant guidance issued by the PCT, Strategic Health Authority or the Secretary of State. 18 Transfer and sub-contracting 18.1 Neither party may assign the whole nor any part of this Agreement, save that the NHS North of Tyne may assign (where not otherwise facilitated under operation of law) where the NHS North of Tyne or part is taken over by another health service body. 18.2 The pharmacy must not sub-contract the supply of services hereunder without the NHS North of Tyne’s previous consent in writing. 19 Staff 19.1 20 The pharmacy shall in respect of all persons employed or seeking to be employed by the pharmacy (whether in and about the provision of the services hereunder or otherwise) comply with each and every provision of law including those, which prohibit discrimination in relation to employment on the grounds of sex, colour, race, ethnic or national origin or religion. Audit 20.1 The pharmacy must allow access by NHS North of Tyne’s internal and/or other nominated auditors to all or any papers relating to this Agreement for the purposes of audit. 20.2 21 The pharmacy must fully co-operate to carry out service evaluation audits as required. Data Protection 21.1 The pharmacy must protect personal data in accordance with provisions and the principles of the Data Protection Act 1998 and must ensure the reliability of their staff that have access to the data. Page 11 of 27 21.2 All pharmacists are required to maintain the confidentiality of client data in line with Caldicott guidance3. Pharmacists are reminded of their obligation within the code of ethics, in particular the maintenance of confidentiality4 21.3 The pharmacy must indemnify NHS North of Tyne against all claims and proceedings and/or liability, loss, costs and expenses incurred in connection therewith made or brought by any person in respect of any loss, damage or distress caused to that person by the disclosure of any personal data by the pharmacy, its staff or agents. 21.4 ‘Personal Data’ has the same meaning as in the Data Protection Act 1998, Section 1 (1). 21.5 Clients records should be maintained in line with record management policy5 21.6 Data transfer via fax must comply with the Transfer of Personal Information Policy6. 22 Complaints 21.1 The pharmacy will be required to have a system for the handling of complaints. All complaints received must be fed back in a timely fashion to the NHS North of Tyne complaints manager. 23 Publicity 21.1 All media queries regarding to the EHC service should be handled with the knowledge of the NHS North of Tyne’s public relations officer and referred to Strategic Manager Sexual Health. Please complete and return the original copy of this agreement to the address below to be countersigned by the Trust; a facsimile copy will be returned to you for your records. Medicine Management NHS North of Tyne Bevan House 1 Esh Plaza Sir Bobby Robson Way Great Park Newcastle NE13 9BA NoT IG&T07 - Information governance policy and strategy V1 — NHS North of Tyne Rpsgb.org: Code of Ethics for Pharmacists and Pharmacy Technicians 5 NoT IG&T01 - Records management policy and strategy V1 — NHS North of Tyne 6 NoT IG&T08 - Transfer of personal information policy V1 — NHS North of Tyne 3 4 Page 12 of 27 Appendix I LARC MONTHLY AUDIT SHEET: Pharmacy Name: ……………………. Completed by: …………………… RPSGB Reg. No: ……… Client’s post code Age Date seen Date submitted: _ _/ _ _/ 200_ Named pharmacist Including RPSGB Reg. No. 1 _ _/ _ _/ 200_ 2 _ _/ _ _/ 200_ 3 _ _/ _ _/ 200_ 4 _ _/ _ _/ 200_ 5 _ _/ _ _/ 200_ 6 _ _/ _ _/ 200_ 7 _ _/ _ _/ 200_ 8 _ _/ _ _/ 200_ 9 _ _/ _ _/ 200_ 10 _ _/ _ _/ 200_ Implanon® inserted or DepotProvera® initiated/ repeated (please state) Chlamydia Screening Y/N Positive result treatment & Partner notification completed NB. Claims for issue of Chlamydia screening test can only be made once and should appear on either this form or the Summary record of EHC consultation form, see Appendix Working on behalf of Newcastle and North Tyneside 3 Primary Care Trusts and Northumberland Care Trust Page 13 of 27 Total Cost Appendix II REFERRAL PROFORMA CLIENT DETAILS Name: ………………………………………. Address: ……………………………………… DOB/AGE: ……………………. LMP …………………….. GP: ………………………………… Pharmacy contact date: dd/mm/yyyy EHC provided: Y/N Reason for referral: ………………………………………………………………………. ……………………………………………………………………………………………………. ……………………………………………………………………………………………………. ……………………………………………………………………………………………………. Referrer (PHARMACY DETAILS): …. ……………………………………………….. Client Preferred Contact Details Preferred method please circle: Mobile/ landline/ letter/text Contact details please provide: mobile/ telephone number or address for correspondence: ……………………………………………………………………………. ……………………………………………………………………………………………………. ……………………………………………………………………………………………………. I have informed the client that they will be contacted by a member of the Sexual Health Service within 1 week of referral. Signed: ………………………………………… RPSGB Reg. No.: ………... Please return by Fax to chosen clinic for follow up appointment: NORTHUMBERLAND Carlton Street Clinic Blyth Northumberland NE24 2DT Tel: 01670 543130 FAX: 01670 543132 NORTH TYNESIDE NEWCASTLE 1 – 1 Centre New Croft House Brenkley Avenue Market Street Shiremoor Newcastle NE27 0PK NE1 6ND Tel: 0191 2970441 Tel: 0191 229 2999 FAX: 0191 2979857 FAX:0191 229 29769 Working on behalf of Newcastle and North Tyneside Primary Care Trusts and Northumberland Care Trust Page 14 of 27 Summary record of EHC consultations Appendix III Month: _____________ Pharmacy stamp/ address: Pharmacist Name: ___________________ Date Staff Initials Postcode Age Reason (1) Test (2) Supply (3) Dose (4) Referral (5) Total number of consultations: Total number of Tablets: Prior (6) Chlamydia test issued Condom Pack Supplied (tick) Time (7) Total number of referrals: Total time taken (minutes): Working on behalf of Newcastle and North Tyneside Primary Care Trusts and Northumberland Care Trust Page 15 of 27 Source (8) Ethnicity (9) Key: (1) Reason for client’s concern: U = unprotected, C = contraceptive failure, M = missed pill, O = other (2) Was a pregnancy test given: P = pre-supply, A = post-supply, B = both (3) Was POEC supplied: Y = yes, N = no (4) What dose was supplied: S = standard dose, A = additional dose after 12 hours, R = repeat dose after vomiting (5) Was the clients referred: N = no, G = GP practice, H = specialist service, P = another pharmacy, S = school health adviser (6) Is the client known to have requested POEC in the previous three months: Y = yes, 0 = unknown, N = no (7) Time taken: enter the time, in minutes taken to complete the consultation and associated records (8) Source: where the client heard about the scheme: M = Media (Newspaper, Radio, Flyer) P = Poster R = Recommendation from a friend/ relative H = Recommendation from a health professional (GP, Nurse, Health Visitor, Sexual Health Clinic) O = Other (9) Ethnicity Codes: White A British B Irish C Any other white background Mixed D White and Black Caribbean E White and Black African F White and Asian G Any other mixed background Asian or Asian British H Indian J Pakistani K Bangladeshi L Any other Asian background Black or Black British M Caribbean N African P Any other Black background Other ethnic categories R Chinese S Ant other ethnic category Not Stated Z Not Stated Form to be returned with the monthly Invoice to: Chelsea Harrison, Medicines Management, NHS North of Tyne, Bevan House, 1 Esh Plaza, Sir Bobby Robson Way, Great Park, Newcastle upon Tyne, NE13 9BA. Form to be returned no later than the 5th of the month. Working on behalf of Newcastle and North Tyneside Primary Care Trusts and Northumberland Care Trust Page 16 of 27 Form IV Record of consultation for Plan B (POEC) (Levonelle 1500®) Pharmacy stamp Client’s name: ………………………………………… Date of consultation: dd/mm/20yy Age / (DOB): XX yrs (dd/mm/yyyy) Ref no: ….. Post code: ……………… Ethnicity………………… Client’s history Date of first day of last menstrual cycle: …………………….. therefore day ………of cycle Has the client had Levonelle 1500® or Levonelle One Step® since last period? ……….. Reason for request: Unprotected……. Failure…… Missed pill…… Other……. Criteria for inclusion Yes No N/A 3rd Is the client beyond the day of a spontaneous menstrual cycle? Has the client missed her contraceptive pill? Advice given if missed contraceptive pill? Client has received POEC but has vomited within two hours (provided UPSI still within 120 hour period) All options for emergency contraception including copper IUD discussed? Clients prefers hormonal method Criteria for exclusion (referral) Did UPSI occur between 72 and 120 hours ago? Has the client used Levonelle 1500 within this cycle? Is the client pregnant or likely to be pregnant? If the client is not using hormonal contraception was her last period more than 4 weeks ago? If the client is not using hormonal contraception was her period abnormal, different Yes No Notes If ‘yes’ discuss copper IUD as first choice but can dispense Levonelle 1500 if within 120 hours If ‘yes’ – discuss more effective contraceptive methods but further Levonelle 1500 can be given If ‘yes’ pregnancy test should be performed. If refused – refer If ‘yes’ perform a pregnancy test or refer. Levonelle 1500 may be given if you are reasonably sure she is not pregnant. If ‘yes’ perform a pregnancy test or refer. Levonelle 1500 may be given if you are reasonably sure she is not Working on behalf of Newcastle and North Tyneside Primary Care Trusts and Northumberland Care Trust Page 17 of 27 length or flow? Does the client have breast cancer? Does the client have severe liver disease? Does the client have porphyria? If under 16 years of age, is the client deemed competent? pregnant. If ‘yes’ – refer If ‘yes’ – refer If ‘yes’ – refer If ‘no’ – refer Additional information: does the client require an increased dose (two tablets of Levonelle 1500 taken as a single dose e.g. malabsorption disease, concurrent liver enzyme inducer? …....... Reason: …………………………………. Counselling Mode of action discussed Failure rate discussed Side effects discussed Possible effects on foetus discussed Dose taken on premises Time of second dose agreed (if increased dose required) Follow-up discussed Future contraception discussed Yes No Other relevant information: Where the client heard about the scheme: ………………………………………………….. Action taken: If supply made: Batch number: Expiry date: dd/mm/yyyy Referral to: Advice given: The above information is correct to the best of my knowledge. I have been counselled on the use of emergency contraception and understand the advice given to me by the pharmacist. Client’s signature: _____________________ Date: dd/mm/yyyy The action specified was based on the information provided to me by the clients, which, to the best of my knowledge, is correct. Pharmacist’s signature:__________________Date: dd/mm/yyyy Time taken to complete consultation ……………. minutes. Working on behalf of Newcastle and North Tyneside Primary Care Trusts and Northumberland Care Trust Page 18 of 27 Appendix V Assessing competence for clients according to Fraser guidelines A young person’s competence to understand their treatment must be assessed. The assessment must be fully documented and should include an assessment of the client’s maturity. The discussion with the client should explore the following issues at each consultation: Assessment of competence Understanding of advice given Yes No Encouraged to involve parents The effect on the physical or mental health of the young person if advice / treatment is withheld Action is in the best interest of the young person Vulnerability/ Safeguarding Assessment Under 16’s Who is the young person accompanied by Age of partner Was sex consensual Suggestions of “grooming” or “abuse” Gifts/bribery Substance/alcohol intake impedes informed decision making? Any other cause for concern Pharmacist’s name: ___________________________(Block capitals) Pharmacist’s signature_____________________ Date: dd/mm/yyyy Client’s name :________________________________(Block capitals) Client’s signature: _________________________ Date: dd/mm/yyyy Working on behalf of Newcastle and North Tyneside Primary Care Trusts and Northumberland Care Trust Page 19 of 27 Record of consultation for long acting reversible contraception (LARC) – Implanon®/ Depo-Provera® Appendix VI Pharmacy stamp Client’s name Date of consultation dd/mm/20yy Age / (DOB) XX yrs (dd/mm/yyyy) Ethnicity Post code Ref no Client’s history Date of first day of last menstrual cycle therefore day _____ of cycle Reason for request How did client become aware of the service? New method of contraception Y/N Alternate method of contraception Y/N Self referral for EHC Y/N Following local awareness campaign Y/N Word of mouth from friend Y/N Criteria for inclusion Has the client chosen to have LARC after receiving counselling on different forms or contraception? Is the client between the 1st and 5th day of menstrual bleeding? If beyond the 5th day of menstrual bleeding provide pre-emptive Levonelle 1500® or condoms via C-Card service. Is client changing from an alternate hormonal contraceptive? If yes what was it? Combined hormonal contraceptive: oral contraceptive/ vaginal ring, trans-dermal patch? or, progestogen only method, mini-pill /injectable /different implant/ intrauterine system? Has the client have a personal or family history of DVT? Yes Does the client have a history of side effects with oestrogen therapy? Is oestrogen contra-indicated in the client Is the client diabetic? Has the client experienced compliance difficulties with other forms of contraception? Does the client smoke? If yes do they smoke > 20 cigarettes or equivalent per day? If Depo-Provera® is being considered have all other methods have been discussed with the patient and considered to be unsuitable or unacceptable? Working on behalf of Newcastle and North Tyneside Primary Care Trusts and Northumberland Care Trust Page 20 of 27 No N/A Criteria for exclusion (referral) Yes __/__ What is the client’s current BP? mmHg Is the client pregnant or likely to be pregnant? Has the client experienced any hypersensitivity reactions to the active substance or to any of its excipients? Does the client exhibit signs of pelvic inflammatory disease? Notes No If ‘BP ≥ 160/100 mmHg refer to GP, if client agrees or to CASH. If ‘yes’ pregnancy test should be performed. If refused – refer If ‘yes’ – refer If ‘yes’ – refer If the patient takes warfarin, refer. Does the client take any other medication? If the patient takes an enzyme inducing drug Implanon® is ineffective, consider DepoProvera® or refer. Does the client have a history of hepatocellular jaundice? Does the client have porphyria? Does the client have a history of arterial or heart disease or migraine with aura? Does the client have breast cancer? If the client is diabetic do they have diabetic nephropathy/ retinopathy/ neuropathy? Does the client have undiagnosed vaginal bleeding? Does the client have a recent history of gestational trophoblastic neoplasia e.g. hydatidiform mole? Does the client have a recent history of pruritis of pregnancy? Has the client requested to see a doctor? If less than 16 years of age, is the client deemed competent? If ‘yes’ – refer If ‘yes’ – refer If ‘yes’ – refer If ‘yes’ – refer If ‘yes’ – refer If ‘yes’ – refer If ‘yes’ – refer If ‘yes’ – refer If ‘yes’ – refer If ‘no’ – refer Counselling Yes Mode of action discussed Failure rate discussed Side effects discussed Client to return for insertion/ injection Date and time for follow up 3 monthly doses agreed (if Depo-Provera® chosen) Follow-up discussed, and appointment made as appropriate. Working on behalf of Newcastle and North Tyneside Primary Care Trusts and Northumberland Care Trust Page 21 of 27 No Other relevant information: If supply made: Implanon®/ Depo-Povera® Batch number: Date & Time (delete as applicable) Expiry date: mm/yyyy insertion/injection: Apply Implanon® label here _ _ :_ _hrs dd/mm/yyyy Referral to (including date): Advice given/ site of insertion or injection/ adverse reactions/ anaphylaxis treatment administered (give full details) : Details of anaesthetic used(give full details): Batch number: Expiry date: mm/yyyy For Implanon® verify the presence of the implant upon completion of the procedure for insertion (delete as applicable) Y N For Depo-Povera® confirm decision follows a discussion on the full range of alternate contraceptive options, including their risks and benefits Y N The above information is correct to the best of my knowledge. I have been counselled on the use of emergency contraception and understand the advice given to me by the pharmacist. Client’s signature: __________________ Date: dd/mm/yyyy The action specified was based on the information provided to me by the clients, which, to the best of my knowledge, is correct. Pharmacist’s signature:_______________ Date: dd/mm/yyyy Time taken to complete initial consultation ……………. minutes. Follow up visit 1st follow up – 12 weeks 2 nd follow up - 24 weeks 3 rd follow up – 36 weeks 4 follow up – 48 weeks 5th follow up – 60 weeks 6 follow up – 72 weeks th th 7 follow up - 84 weeks 8th follow up – 96 weeks th Date and time of follow up DepoProvera® Pharmacist’s signature Client’s signature 9th follow up – 108 weeks 10th follow up – 120 weeks 11th follow up – 132 weeks 12th follow up – 144 weeks Working on behalf of Newcastle and North Tyneside Primary Care Trusts and Northumberland Care Trust Page 22 of 27 Appendix VII Partner Notification Form Treatment Site: Treatment Date: Index Client’s Name: Gender: D.O.B: CH No: M / F Number of Partners in last 6 months: Please obtain details of all partners within the last 6 months. If no partners within the last 6 months, please obtain details of the most recent partner Partner No: Name: Gender: D.O.B: Phone: M / F Address: Postcode: PSI: Always LSI: Sometimes Partner Referral Method: Never Client If ‘Provider’ Indicate method of Contact: Length of relationship: Provider Telephone Non-contactable Letter If ‘Client’ please tick one of the following: Attended with client Client will inform Contact slip issued Partner already informed Partner already treated If already treated, Location: ______________________ Partner No: Name: Gender: D.O.B: Phone: M / F Address: Postcode: PSI: Always LSI: Sometimes Partner Referral Method: Never Client Length of relationship: Provider Non-contactable Working on behalf of Newcastle and North Tyneside Primary Care Trusts and Northumberland Care Trust Page 23 of 27 If ‘Provider’ Indicate method of Contact: Telephone Letter If ‘Client’ please tick one of the following: Attended with client Client will inform Contact slip issued Partner already informed Partner already treated If already treated, Location: ______________________ Index Client’s Name: Gender: D.O.B: CH No: M / F M / F Partner No: Name: Gender: D.O.B: Phone: Address: Postcode: PSI: Always LSI: Sometimes Partner Referral Method: Never Client If ‘Provider’ Indicate method of Contact: Length of relationship: Provider Telephone Non-contactable Letter If ‘Client’ please tick one of the following: Attended with client Client will inform Contact slip issued Partner already informed Partner already treated If already treated, Location: ______________________ Partner No: Name: Gender: D.O.B: Phone: M / F Address: Postcode: PSI: Always LSI: Sometimes Partner Referral Method: Never Client If ‘Provider’ Indicate method of Contact: Length of relationship: Provider Telephone Non-contactable Letter If ‘Client’ please tick one of the following: Attended with client Client will inform Contact slip issued Partner already informed Partner already treated If already treated, Location: ______________________ Working on behalf of Newcastle and North Tyneside Primary Care Trusts and Northumberland Care Trust Page 24 of 27 Appendix VIII Northumberland Tyne and Wear Chlamydia Screening Programme Pharmacy Treatment Sheet Date/ Time:……………..…… Treatment venue:……………………………….…… Name:………………........................................... CH no: ………..…….………….. Please tick: Contact client IP No: ........................................ Index client D.O.B:…...………….. Age: ……... Under 16 Assessing competence for clients according to Fraser guidelines completed YES/NO Address:………………………………..……………………………………………….. ……………….……………………………………………………………………..…. Post Code:…………………Telephone…………..……………….………………….. Previous STi’s Diagnosis : Chlamydia – Discuss Previous Test yes/no Result Neg/Pos Symptoms: Discharge* IMB* PCB* BTB* Pelvic pain/dyspareunia* Scrotal Pain* Dysuria* Conjunctivitis and /or joint pain Fever* Feeling unwell* Asymptomatic* Other: Referred to GUM/GP Relevant past medical history: Current medication: Referral letter Yes/No LMP: Menstrual cycle Present contraception Any risk of pregnancy Yes/no Breast feeding Yes/no PT neg. / pos./ not indicated Details: Allergies: Drug Use discussed: Yes / No Drugs used: LSI: Casual/ Regular Partner (Current/Ex) Type: Oral Vaginal Anal (advise risks) Sexual orientation: Heterosexual, Gay, Lesbian, Bi-Sexual, Transsexual Condom use: always / occasionally / never C-card Aware of C-Card Scheme? Yes/No Safe sex discussed? Yes/No Working on behalf of Newcastle and North Tyneside Primary Care Trusts and Northumberland Care Trust Page 25 of 27 Treatment Given Date Prescription Brand or Manufacturer Batch no & expiry Signature Azithromycin po BN: 1gm stat dose Verbal consent obtained Treatment Supervised (sign to confirm & date) Y/N Exp: Doxycycline po BN: 100mg bd x 7 days Y/N N/A Exp: Erythromycin stearate po 500mg BN: bd x 14 days Exp: Y/N If Pregnant discuss treatment options: Yes/No Partner Notification (complete partner notification form/s) Tick Discussed Box Advised to attend GUM for full screening Contact details given for GUM/ Sexual Health Services Possibly COC interaction & 7–Day rule Doxycycline / Azithromycin - Photosensitivity Erythromycin - Need for “Test of Cure” in 5 weeks Discuss common/ rare side effects. To contact GP/NHS direct if concerned. Vomiting within next 3 hours, advised to contact pharmacy for retreatment Discuss alcohol intake while on treatment Info leaflet given - Chlamydia FPA / CSO*/antibiotic Pt. info. Condoms given and advised no sex/ sexual contact while on treatment and next 7 days Advised re-testing after every partner change or anytime if risk of re-infection Given post treatment information sheet Client Advised they will be contacted by CSP Health Advisor for compliance Outcome Compliant / Non-compliant / Non-contactable* Signature / Name…………………………………………………………………… Date: ……………………....……………..… Case closed to file: Time: ……………………… Yes / No Please Fax to Central Office 0191 229 2982 Working on behalf of Newcastle and North Tyneside Primary Care Trusts and Northumberland Care Trust Page 26 of 27 Appendix IX Care Pathway for provision of specialised, enhanced sexual health services via community pharmacies Client makes request for EHC post UPSI Client makes request for LARC How old is the ♀? Microbiology confirmed positive Chlamydia result CSO give Clients: N ≥ 16 yrs Y Is the clients deemed competent? (According to Fraser guidelines) - CH number - Location of pharmacies in scheme - Contact details for pharmacy and opening times Clients contacted by CSO who communicate to clients via chosen method. Health advisor provides treatment options Y N Chlamydia screening kit issued & advice for completion given Does clients meet PGD criteria for inclusion? Direct referral to CaSH for alternative emergency contraception Clients requests treatment via pharmacy Clients fails to attend pharmacy within one week of positive result Y N CSO contact pharmacy and informed Counselling completed EHC provided Pharmacy informs CSO Clients attends pharmacy for treatment, to be treated according to PGD Future contraception discussed, and LARC offered Signpost/refer to clients’s GP ≤ 19 yrs N Y Offer of LARC accepted Direct referral to CaSH for alternative preferred contraception i.e. coil or O/C Fax all completed paperwork to CSO Provide condoms and consider provision of preemptive EHC Y N At time of administration is clients’s BP ok? Y N Treatment given in accordance with PGD & paperwork completed N Does clients meet PGD criteria for inclusion? Y Undertake administration of LARC at mutually convenient time N Y Is LARC to be administered between days 1 – 5 of menstrual cycle? First line of Partner Notification completed Partner Notification follow up and compliance check as agreed with clients via CSO Health advisor Working on behalf of Newcastle and North Tyneside Primary Care Trusts and Northumberland Care Trust Page 27 of 27 Attendance follow up by CSO Does clients meet PGD criteria for inclusion? Direct referral to CaSH for follow up Offer written information on Chlamydia aetiology & discuss relevant health promotion and potential referral to CaSH for GUM appointment