Community Pharmacy Emergency Hormonal Contraception Service Author: Peer Reviews: Produced January 2010 Review date- April 2013 Ruth Buchan Julie Landale Medicines Management 4th Floor F Mill Dean Clough Halifax HX3 5AX Tel-01422 281300
2
Contents Executive Summary... 4 Aims and intended service outcomes of the service... 4 Brief service description... 4 Resource implications... 4 Purpose of the Agreement... 5 Selection of provider... 5 The Services... 5 Client presents in pharmacy... 5 EHC consultation... 6 Advice to be provided... 6 Information to be provided... 6 Referral... 6 Excluded clients... 7 Accessibility... 7 Payment... 8 Formulary... 8 Staff... 8 Core Competencies... 9 Accreditation... 10 Underpinning Knowledge... 10 PCT Commissioned Workshop... 11 Premises... 11 Resources to support delivery of the service... 12 Quality Indicators... 13 Service Evaluation... 14 3
Executive Summary The NHS supply of EHC through Community pharmacists has a crucial role in preventing unwanted pregnancies by providing fast, convenient, local access to EHC without an appointment, often out of hours, maximising the effectiveness of EHC by as much as 10% 1. Additionally, supply of EHC on the NHS from community pharmacists has been well received by service users 2. Reducing teenage pregnancy is a priority, including females between 13 years and 25 years of age in the service should contribute to the reduction in teenage pregnancy rates and as such should be seen as an invest to save measure 3. Aims and intended service outcomes of the service The Emergency Hormonal Contraception Service (EHC Service) aims to: Increase access to Emergency Hormonal Contraception (EHC) and sexual health advice Increase choice of health care professionals who can provide EHC free of charge Reduce the rate of unintended pregnancies, in particular among women under 25 years of age Directing clients who fall outside the protocol or who need advice on ongoing contraception into mainstream contraceptive services and appropriate healthcare services. Brief service description Females between 13 and 25 years of age who present within 72 hours of unprotected sexual intercourse will be provided with emergency hormonal contraception (subject to clinical circumstances) free of charge. Additionally, females who present within 72 hours of unprotected sexual intercourse who are in receipt of an income based prescription exemption (income support, income based jobseekers allowance or working families tax credit) will be offered emergency hormonal contraception (subject to clinical circumstances) free of charge. Clients will also be given advice on the avoidance of pregnancy and sexually transmitted infections (STIs) through safer sex and condom use, advice on the use of regular contraceptive methods and provide onward signposting to services that provide long-term contraceptive methods and diagnosis and management of STIs. Resource implications Pharmacies will be paid 15 per consultation to cover pharmacist and staff time, training and other duties as outlined in the services. EHC is reimbursed at cost price (based on drug tariff, Chemist and Druggist or wholesalers list price) plus VAT. 1 Pharmaceutical Journal 2006;276:583 2 Choosing health through pharmacy 2005-2015 A programme for pharmaceutical public health http://www.dh.gov.uk/assetroot/04/10/74/96/04107496.pdf 3 Teenage Pregnancy Next Steps: Guidance for Local Authorities and Primary Care Trusts on Effective Delivery of Local Strategies. Available at: http://www.everychildmatters.gov.uk/_files/8845f3c6ec567906d4e1f95616ed6bfb.pdf 4
Service Specification This service specification is underpinned by the Agreement for the provision of Community Pharmacy Enhanced Services (LES Agreement). The LES agreement specifies the terms of service, including duration of agreement, performance management, and should be read in conjunction with this Service Specification. Purpose of the Agreement This agreement relates to the Emergency Hormonal Contraception (EHC) Service by participating community pharmacies within. The agreement is for the pharmacy to supply Levonorgestrel Emergency Hormonal Contraception (EHC) to appropriate clients, in line with the requirements of the patient group direction, by accredited pharmacists from accredited community pharmacies within NHS Calderdale. Selection of provider The Pharmacies for this service have been selected on the basis of: 1. Availability of a suitable consultation area (as defined for the Medicines Use Review service) The Services Any client registered with a Calderdale GP practice is eligible to receive advice and treatment under this service. Clients who present to the pharmacy but are not registered with a Calderdale GP must be signposted as outlined as stated below under Excluded clients p7. Client presents in pharmacy Pharmacies will ensure they offer a user-friendly, non-judgmental, clientcentred confidential service. Pharmacies will ensure that staff refer clients requesting EHC to the accredited pharmacist discreetly and as soon as practicable. See Accessibility section p7 for action to be taken if accredited pharmacist not available. Clients who present for over-the-counter (OTC) EHC will not be diverted to this service unless the client states that the cost of OTC EHC is prohibitive and will prevent them from accessing OTC EHC. 5
EHC consultation The complete EHC consultation must be carried out within the pharmacy consultation room (see premises p11). The EHC consultation must be carried out by a pharmacist who is accredited with NHS Calderdale to provide the EHC service (see accreditation p10) The pharmacist will assess the need and suitability for a client to receive EHC, in line with the PGD and service specification. The consultation must be documented on the Patient Record Form. Inclusion and exclusion criteria detailed in the PGD and service specification will be applied during the provision of the service. Where appropriate supply of EHC will be made free of charge to the client. Supply should be recorded on the patients PMR. If the client does not have a PMR entry one must be created on which to record EHC supply. The pharmacist will normally supervise the administration of the EHC, unless a valid reason is given not to administer the EHC at that time, in which case the EHC will be dispensed and the client informed to take EHC as soon as it is possible. If the pharmacy provides the Chlamydia screening service all clients under 25 should be offered a Chlamydia screen. The PCT supports the RPSGB guidance that states that If a pharmacist thinks that EHC is not required but the female perceives risk, and despite the pharmacists advice still wishes to take EHC the pharmacist can consider making a supply. Supply in this instance is covered by the PCT PGD and will be paid under this agreement. Although the RPSGB has issued guidance regarding advance supply of EHC this is not covered by the PDG therefore pharmacists are unable to make an advanced supply using this service. If a request is made for advance supply a pharmacist can offer OTC purchase if they feel it is appropriate. Advice to be provided The pharmacist will provide support and information to clients accessing the service including: the avoidance of pregnancy and sexually transmitted infections through safer sex and condom use how to use condoms the use of regular contraceptive methods where and how to access services that provide long-term contraceptive methods where and how to access STI services where and how to access further advice and care. NB this advice is to be provided whether or not EHC is provided Information to be provided Clients should receive an age appropriate selection of information leaflets covering sexual health, on-going contraception and services. These will be supplied by the PCT, with guidance on target age range. NB This information is to be provided whether or not EHC is provided. 6
Referral Record referrals on the Referral Form Clients who have exceeded the time limit for EHC must be informed about the possibility of use of an IUD and should be referred to a local service, such as CaSH or GP, as soon as possible. Refer any client who is identified as unsuitable for the supply of Emergency Hormonal Contraception under the PGD or service specification to a GP or CaSH. If a referral is made the pharmacist should make every effort to contact the GP/ CaSH clinic, book an appointment for the client and inform the client of the time and location of the appointment. Pharmacists should link into existing networks for community contraceptive services so that clients who need to see a doctor or appropriate healthcare professional can be rapidly referred. Excluded clients Clients excluded from the PGD criteria or service specification criteria will be referred by the pharmacy to another local service that will be able to assist them, as soon as possible, e.g. GP, community contraception service, or will be invited to purchase the Pharmacy medicine product if the exclusion from supply via the PGD is only due to an administrative matter, e.g. client not registered with a Calderdale GP, over 25 but not in receipt of an incomebased prescription exemption (income support, income-based job seekers allowance, named on a valid working families Tax Credit NHS exemption certificate or HC2 full help with health costs certificate). If the client is excluded from accessing EHC due to a service specification exclusion (i.e. accredited pharmacist not available, client not registered with Calderdale GP, over 25 and not in receipt of an income-based prescription exemption) the pharmacist cannot claim a consultation fee as this exclusion should be ascertained before the consultation. If following a consultation, a client is excluded or otherwise unable to access EHC the pharmacist can claim the usual fee for the consultation as long as the advice, information and referral has been provided to the client as outlined in the PGD and service specification. Accessibility The expectation is that the service is available throughout the pharmacies opening hours (both core and supplementary). The service is to be delivered by the pharmacy for at least 45 weeks of the year with no continuous break of more than two weeks. When the pharmacy is unable to provide the service the pharmacy has a duty to signpost any potential clients to another provider of EHC, convenient to the client, who are able to provide the service to the client. This may be another pharmacy, CaSH or GP. The client must be informed of all possible providers. 7
The pharmacy must ensure that the service to which the client chooses to be referred to is able to provide the service in terms of opening times, availability of suitable staff etc. In the case of referral to another pharmacy this would include phoning the pharmacy to check that an accredited pharmacist will be available to provide the EHC service for the client. These checks must be made before the client leaves the pharmacy. The pharmacy should also consider whether it is appropriate to provide clients being referred or signposted with information leaflets regarding emergency contraception, ongoing contraception and sexual health. The pharmacies procedure for dealing with a client who presents for EHC when an accredited pharmacist is not available must be detailed within a SOP, accessible to all pharmacy staff to ensure that any client who presents to the pharmacy is dealt with in an appropriate and timely manner in line with this service specification. Payment Remuneration will be made to the pharmacy according to the following: Service delivery costs will be paid at 15 per consultation to include: Pharmacist time to provide the consultation Associated staff time to support the pharmacist in providing the service Training costs Printing and providing information sheets Completing claim forms and audit. Treatments are reimbursed at cost price (based on drug tariff, Chemist and Druggist or wholesalers list price) plus VAT at the appropriate rate (currently 5%) as stated in the Formulary p8. Payment will be made retrospectively on a monthly basis on receipt of an EHC client summary form for each client and monthly formic submission form at the PCT. NB All claims must be submitted to MONTHLY SUBMISSION, Medicines Management, 4 th Floor, F Mill, Dean Clough, Halifax HX3 5AX Formulary The pharmacy will hold adequate stocks (taking into consideration the possibility of an unexpected increase in demand) of EHC to ensure that clients can immediately access the necessary treatment. Levonelle tabs 1500mcg Bayer Schering (1) = 5.37 Prices correct at December 2009. The PCT will notify contractors of change in prices by letter. 8
Staff Pharmacies operating the service must be authorised by the PCT to provide the service. This is via a schedule of services authorisation signed by both the EHC service commissioner and the community pharmacy. Each individual pharmacist providing the service must: be registered with the PCT to provide the EHC service have signed the current version of the NHS Calderdale EHC PGD retained in the pharmacy have a satisfactory CRB advanced check carried out by the PCT completed (and maintained) the required training be in possession of a current, expiry dated EHC service certificate provided by the accrediting PCT (this may be other than ) The pharmacist named in the Locally Enhanced Service (LES) agreement must ensure that all pharmacy staff, including part-time staff and locum pharmacists, receive appropriate training and are aware of the service, how it operates including relevant signposting information and referral procedures, to ensure the pharmacy offers an effective, sensitive and non-judgemental service. Core Competencies All pharmacists providing the EHC Service have a professional responsibility to develop, reinforce and update their knowledge and skills in the following areas: a) Able to communicate with clients appropriately and sensitively [G1, G2]. b) Able to counsel and advise on emergency contraception and regular methods of contraception [G2, G7]. c) Understands how and when to refer clients and when to ask for support and advice [G7]. d) Understands confidentiality issues and is aware of their role in the process of child protection [G8]. e) Understands the different types and methods of hormonal contraception and non-hormonal contraception; their use, advantages, failure rates and complications [G1,]. f) Understands the pharmacotherapy for the full range of available medication and appropriate clinical guidance (e.g. NICE). [G1] g) Understands and is able to apply the medico-legal aspects of EHC provision in accordance with a Patient Group Direction [G5]. h) Able to demonstrate knowledge of the clinical content of the relevant Patient Group Direction(s). [G1] These core competencies have been linked, where appropriate, to the general pharmacist competences of the Royal Pharmaceutical Society of Great Britain which are shown in [ ] and are mapped to the General Level Framework (available at www.codeg.org). 9
Accreditation Pharmacists must be accredited to provide the service. To gain accreditation each pharmacist must have attended the PCT Commissioned Workshop session(s) and successfully completed the: a) CPPE Emergency Contraception Open Learning Programme and accompanying assessment prior to attending the workshop. b) CPPE Contraception Open Learning Programme and CPPE Child Protection Open Learning Programme and their accompanying assessments either prior to or within 3 months of the workshop. c) Role Play assessment to an acceptable standard. The PCT recognises that pharmacists who became accredited prior to 2010 were not accredited to these standards (as defined by the Harmonisation of Accreditation Group (HAG)); however their accreditation is still valid and they can continue to provide the Calderdale EHC service. Accreditation is proven by possession of a current, expiry dated certificate provided by the accrediting PCT which, if relevant, bears the HAG standard mark. Pharmacists are expected to re-validate their accreditation at least every three years. This should be in the form of a self-declaration of competency or other method of assessment as considered appropriate by. Underpinning Knowledge Three Centre for Pharmacy Postgraduate Education (CPPE) learning packs provide pharmacists with the necessary knowledge to underpin the provision of EHC as an enhanced service: CPPE Emergency Contraception Open Learning Programme (3 Hours) CPPE Contraception Open Learning Programme (12 Hours) CPPE Child Protection Open Learning Programme (1.5 Hours) Successful completion of the Emergency Contraception Open Learning Programme and the assessment is a pre-requisite to attending the PCT Commissioned Workshop. The Contraception and Child Protection Open Learning Programmes and their assessments should be completed before or within 3 months of attending the Workshop. The CPPE programmes provide pharmacists with a record of assessment which must be retained by the pharmacist and copies sent to the PCT. Alternatively, individuals can also allow access to their online records by switching on the CPPE viewer via the My CPPE page on the CPPE website (www.cppe.ac.uk). Although not mandatory a CPPE Open Learning Programme is available for those Pharmacists who are not familiar with the concept of Patient Group Directions and wish to learn more. 10
PCT Commissioned Workshop a) Aim of workshop To enable Community Pharmacists to become competent to provide an EHC service that includes the supply of a Prescription Only Medicine in accordance with a Patient Group Direction, and understand the clinical, ethical, cultural and legal aspects of this work. The workshop will address relevant clinical issues linked to such medicine use. b) Objectives of workshop The workshop should review and support the underpinning clinical knowledge required to provide an EHC service. Pharmacists should experience problematic situations through role-play, and gain confidence in dealing with them. On completion of the training, pharmacists are able to: I. Understand the aims of an EHC service and its place in Contraception and Sexual Health Services overall. II. Understand confidentiality issues and be aware of safeguarding children and vulnerable adults. III. Understand and apply the medico-legal aspects of aspects of the Patient Group Direction - especially as applied to under-age females (i.e. under 16yrs) [Fraser Ruling]. IV. Undertake the administration of the Patient Group Direction(s), including all necessary record keeping and associated paperwork **. V. Apply the clinical content of the Patient Group Direction(s). VI. Be aware of the details of when to carry out a pregnancy test, and the actions to be taken following the result. VII. Understand how and when to refer clients (signpost) and when to ask for support and advice from the local Contraception and Sexual Health Services. VIII. Counsel and advise clients appropriately and sensitively, and refer for further contraceptive care. IX. Know what sources of support are available to the pharmacists involved in the provision of this service. c) Features of the Workshop A Contraception and Sexual Health Clinician(s) will be present and participate in the running of the Workshop. The Workshop will include various appropriate role-play scenarios and assessment. A facilitator will observe and/or participating in the role-play in order to assess each pharmacist. Pharmacists performance must be to an acceptable standard. Premises The EHC service must be carried out within the pharmacy consultation room (as defined by for the MUR service). EHC consultations must not take place over-the-counter or in another area of the pharmacy shop. The pharmacy will display the EHC Poster in a prominent position in the pharmacy window to advertise that the pharmacy provides the service. 11
Resources to support delivery of the service The PCT will provide the necessary leaflets and claim forms for service delivery. Leaflets are to be ordered from the Public Health Resource Centre and service delivery forms are to be ordered from Medicines Management using the stationary order form. At least 4 weeks should be allowed for delivery of items. The orders will be delivered by the internal mail van. Information leaflets For leaflet orders please contact: Calderdale Public Health Resource Centre, School House, 56 Hopwood Lane, HALIFAX HX1 5ER Tel: (01422) 397340 or email at: tony.burgin@calderdale-pct.nhs.uk or janet.klievens@calderdale-pct.nhs.uk List of resources: Local Services Leaflet (PCT) Your sexual health: Where to go for help and advice (FPA) Emergency contraception (FPA) The IUD (FPA) A guide to male and female condoms (FPA) Your guide to contraception (FPA) Body works (FPA) Pregnant and don t know what to do? (FPA) Teenagers- Your choice of contraception NB- a larger range of leaflets is available but the ones listed above are considered to be core leaflets required to provide the service. Service delivery paperwork Please order from Medicines Management, 4 th Floor, F Mill, Dean Clough, Halifax HX3 5AX List of resources: Underpinning LES agreement Service Specification NHS Calderdale Community Pharmacy EHC Patient Group Direction Referral form EHC consultation record EHC client summary form Confidentiality poster EHC window sticker Monthly Formic Form Submission to PCT Storage of paperwork Completed paperwork must be stored as outlined in the Locally Enhanced Service (LES) agreement. However, as this service supplies medication via a PGD to those under 18, additional requirements are needed for storage: The record of consultation must be retained for a minimum of 8 years from the consultation date, and for under 18 s until the patient s 25th birthday, or 26th if young person was 17 at conclusion of treatment. 12
After this time the patient records should be destroyed in line with NHS code of practice for records management. If a PGD is superseded, the superseded PGD must be retained, along with a list of those authorised to work under the PGD, until any client who had a supply made under the PGD reaches 25 years old (i.e. retain for a minimum of 12 years) Quality Indicators Performance monitoring Quality Performance Indicator The pharmacy is making full use of the promotional material made available for the service and promotes its uptake Threshold 100% compliance Method of Measurement PCT Contract Assurance process (including selfassessment) Mystery shopper feedback Report Due Frequency of assurance visit as determined by the PCT Performance monitoring The pharmacy has the agreed information leaflets and ensures that relevant written information is provided at each consultation 100% compliance PCT Contract Assurance process (including selfassessment) Mystery shopper feedback Frequency of assurance visit as determined by the PCT Performance monitoring The pharmacy has appropriate PCT provided health promotion material/ service publicity available for the user group and promotes its uptake. 100% compliance PCT Contract Assurance process (including selfassessment) Frequency of assurance visit as determined by the PCT Clinical Governance- Patient Safety The pharmacy ensures that the SOP is in line with the service specification and reviews this SOP and the referral pathways for the service on an annual basis. 100% compliance PCT Contract Assurance process (including selfassessment) Mystery shopper feedback Frequency of assurance visit as determined by the PCT 13
Suitably Qualified Workforce Quality Performance Indicator The pharmacy can demonstrate that pharmacists and staff involved in the provision of the service have undertaken CPD and/ or training relevant to this service Threshold 100% compliance Method of Measurement See accreditation section PCT Contract Assurance process (including selfassessment) Report Due Annual renewal of service agreement Improving Service Users & Carers Experience Improving Service Users & Carers Experience The pharmacy participates in an annual PCT organised audit of service provision The pharmacy cooperates with any locally agreed PCTled assessment of service user experience 100% compliance 100% compliance Return of all audit forms within timescales specified by PCT. Evidence of all patient suggestions to enhance service and the investigation of these together with summary of outcome, e.g. taken forward/not taken forward as impractical PCT full service review (expected every 3 years) although information may be required for the PCT annual service review report PCT full service review (expected every 3 years) Service Evaluation The service will be annually reviewed to ensure it is working correctly, meets the needs of patients, healthcare professionals and the NHS and to check whether any improvements could be made. Feedback will be to the LPC/PCT and any other stakeholder PCT groups (e.g. Medicines Management Committee) using the following criteria: Number of consultations per pharmacy, postcode area and in Calderdale Trends in numbers accessing the service through each pharmacy, postcode area and in Calderdale Frequency of client use The reason for the request Analysis of exemption and inclusion criteria for each client Length of time between of unprotected sexual intercourse and EHC consultation The numbers of EHC supervised compared to not-supervised Impact on pharmacist time 14
Costs of service Assessment of user experience (if included) Number of incidents reported to the PCT regarding the service and if appropriate an analysis of the incidents Feedback from mystery shoppers (if carried out) Feedback received from stakeholders about the service (if included) Documentation used in the preparation of this service PSNC service specification: EHC East and South East England Specialist Pharmacy Services: Pharmacy support for Community Health Services (CHS) a toolkit for developing Service Level Agreements (SLAs) for pharmacy support 15