Draft - Solihull Nhs Care Trust

SOLIHULL NHS CARE TRUST

LOCAL ENHANCED SERVICES HORMONAL EMERGENCY CONTRACEPTION

Hormonal Emergency Contraception

Contract Between

Solihull NHS Care Trust

and

…………………………………….Pharmacy

1. Aims

To provide oral hormonal emergency contraception to female clients, 13 years and over, who present in person at the Pharmacy, and request it within 72 hours following unprotected sexual intercourse (UPSI), as defined in the Assessment Protocol (see appendix one), to prevent an unwanted pregnancy.

1. Service Outline

The Pharmacist must perform the consultation themselves and must not delegate the service to other pharmacy staff.

Medicines Counter Assistants will be trained to refer all HEC requests promptly and discreetly directly to the pharmacist.

Pharmacists and other pharmacy staff must be sensitive and non-judgmental toward females requesting HEC, giving due regard to the customer’s right to privacy and confidentiality.

Pharmacists will need to demonstrate that they are providing this service in line with the protocol attached in appendix one.

The outline of this is:

• A clinical assessment must be undertaken, using the Assessment Protocol and by completing the Proforma for Hormonal Emergency Contraception.
• In exceptional circumstances, such as ‘Out of Hours’ and/or when it is not possible for the client to access a doctor or family planning clinic, it may be appropriate for the Pharmacist to supply Levonelle 1500 if:
• The client has previously taken HEC in the current cycle, and further UPSI has taken place later in that cycle, or
• The client has been supplied with, and taken Levonelle 1500 for emergency contraception earlier in the day but has been sick within 3 hours of taking the dose, and she is still within the 72 hour time period for POEC.

• In all cases the Pharmacist must make a clinical and professional judgment, and be fully satisfied that such a supply is in the best interest of the client under the circumstances.
• The Pharmacist’s actions must be clearly documented on the proforma.
• If the client is excluded from receiving HEC from a pharmacist under the terms of the LES, the pharmacist should complete a referral form and make arrangements for the client by:
• Contacting a doctor by phone to book an appointment or
• Signposting to an alternative provider (i.e. Family Planning Clinic) or
• Signposting to the Accident and Emergency Department at SolihullHospital if no other service is available
• If there is not a Pharmacist available in the Pharmacy to supply HEC under the PGD and LES, the Pharmacy staff should signpost the client to either:
• An accessible Pharmacy that can offer the service
• A Family Planning Clinic
• A GP Practice
• A&E if no other service is available

• In all cases the Pharmacy must telephone ahead to ensure that there is a Pharmacist on duty that can make a supply under the LES, that a clinic is running, or that a GP appointment is available.

• The pharmacy contractor has a duty to ensure that pharmacists and staff involved in the provision of the service have relevant knowledge and are appropriately qualified and trained in the operation of the service.
• The pharmacy contractor has a duty to ensure that pharmacists and staff involved in the provision of the service are aware of and operate within the local protocols.
• The pharmacy should maintain appropriate records to ensure effective ongoing audit and service planning.
• The pharmacist must complete Solihull Care Trust’s Hormonal Emergency Contraception proforma, consisting of 2 sheets, an original and a duplicate sheet.
• The client must read and sign the client’s declaration
• The Pharmacist must stamp, sign and date the Pharmacist’s declaration in coloured ink.
• The top copy of the proforma should be retained securely and confidentially in the Pharmacy for audit purposes.
• The bottom duplicate sheet, which is anonymised, should be submitted to the CT, at the end of each month for re-imbursement of the Levonelle-1500 supplied and payment of the consultation fee.
• The pharmacist must record the supply on the Pharmacy’s computerised PMR, create a PMR number for the client, and label the product in accordance with the Medicines Regulations.

1. Training

• Pharmacists currently on the RPSGB register.
• Pharmacists who have completed an approved HEC training session, have undertaken a self-assessment and deem themselves competent
• Have completed the following CPPE open learning programmes within 3 months of attending an approved HEC training session and sent copies of accreditation certificates to Medicines Management:

• Emergency Contraception
• Contraception
• Safeguarding Children

• Are registered with Solihull CT as participating in the scheme by signing up to the PGD and having received a letter of confirmation from the CT
• All pharmacists registered with Solihull CT as participating in the scheme by signing up to the PGD (PGD 35 version 2) prior to October 7th 2009 must sign up to the latest version of the PGD as soon as possible and complete the above CPPE open learning programmes and send copies of certificates of accreditation to Medicines Management by 30th September 2010 to maintain accreditation after this date.
• The pharmacist will be conversant with the contents of the Levonelle 1500 SPC, the CT Assessment Protocol for Pharmacists issuing HEC, have access to the Pharmacy HEC training documentation pack and the latest edition of BNF for reference.
• Pharmacists should maintain their level of competence; evidence of CPD may be requested by the CT for continued inclusion on the register of participating pharmacists.

1. Quality Indicators

• The pharmacy reviews its standard operating procedure and the referral pathways for the service on an annual basis.
• The pharmacy participates in an annual Care Trust organised audit of service provision if requested to do so.
• The pharmacy co-operates with any locally agreed Care Trust-led assessment of service user experience.

1. Payment Schedule

• The Care Trust will pay each Pharmacy contracted to provide this service:
• Fee of £12.00 per consultation with client, where all appropriate procedures are followed and records kept, as detailed in this agreement.
• Fee of £5.50 where the drug is administered.

This schedule is current at the time of issue; annual updates to the payment schedule will be sent to pharmacists.

• Payment will only be made on receipt of a HEC proforma.
• The Care Trust will make payments on a monthly basis against a claim form.
• HEC proformas must be sent with a claim form at the end of each month to be processed for payment. If proformas are sent more than 3 months after the end of the month in which the supply was made they may not be processed for payment.
• Proformas completed in the month of March may not be processed for payment if received after 30th April in the same year.
• The Care Trust maintains the right to suspend payments to pharmacists under this agreement should there be any cause for concern in relation to terms of the agreement not being maintained or if there are grounds for concern around the quality of the service. These issues will be discussed with the practice as part of the contract monitoring and quality assurance process.

1. Disputes

• In the event of disagreement or dispute, the Care Trust and the pharmacist manager will use best endeavours to resolve the dispute without recourse to formal arbitration. If unsuccessful, the matter will be determined in accordance with the normal contractual dispute resolution procedure.

1. Termination

• Either party may terminate this agreement by giving at least three months’ notice of termination, or sooner by mutual agreement; and give at least three months’ notice to clients of discontinuation of service.
• The Care Trust reserves the right to review and update this service specification in line with national recommendations and /or best practice. Three months’ notice will be given of these changes where possible. Pharmacists will be required to take appropriate action accordingly.
• The Care Trust may give immediate notice of termination if a pharmacy fails to carry out its obligations appropriately.

Local Enhanced Service Hormonal Emergency Contraception

Signed on Behalf of Solihull Care Trust:

Name:Title:

Signature: Date:

Signed on behalf of the Pharmacy:

Pharmacist Name:

Signature: Date:

Appendix One

PROTOCOL AND PROCEDURE FOR PHARMACISTS ISSUING HEC (Levonelle)

Step 1: CLINICAL ASSESSMENT

Details of recent unprotected sexual intercourse (UPSI) will need to be ascertained including the following:

• date of first day of last period

• usual cycle length

• length of last period (i.e. was it normal?)

• date, time and day of cycle of UPSI

• any other UPSI this cycle and, if so, when?
• work out time in hours since episodes of UPSI

Indications for Hormonal Emergency Contraception (HEC):

• no method of contraception used
• coitus interruptus/failed coitus interruptus
• ejaculation onto external genitalia
• miscalculation of rhythm method
• condom rupture, dislodgement or misuse
• Femidom dislodgement or misuse
• diaphragm inserted incorrectly, dislodged, removed too early or found to be torn
• complete or partial expulsion of IUD
• removal of mid-cycle IUD
• Persona mistakes - If HEC is given to women using Persona, they must be advised that they will not be able to rely on this method of contraception for two normal menstrual cycles following HEC
• Potential pill failure when the efficacy of regular combined or progestogen-only contraceptive pills is compromised and additional methods have not been used and/or failed (see table below):

Exclusions from the LES and Criteria for Referral for Medical Advice:

Special Considerations

Considerations should be given to referral to a family planning clinic or GP for IUD fitting as an emergency if appropriate, and also for ongoing contraception.

N.B. Unless excluded, Levonelle 1500 should be issued, even if the client is referred for an IUD (in case she does not attend for the procedure, or insertion of an IUD is not possible).

• If the client has had a previous ectopic pregnancy, the pharmacist should explain that emergency contraception does not appear to increase the risk of an ectopic pregnancy occurring, but it may be less effective in preventing an ectopic as opposed to a uterine pregnancy. The client should therefore be especially alert to the possible warning signs of an ectopic pregnancy.

• If a woman is breastfeeding, she should be advised to express breast milk before taking Levonelle 1500 and bottle feed for 24 hours.

• Patients taking a liver enzyme inducing drug* may be given an increased dose of two tablets of Levonelle 1500 as a single dose as soon as possible and within 72 hours of UPSI. This is recommended by the Faculty of Family Planning but is outside the product licence. Patients should be advised that the IUD is the preferred option in this case.

*Drugs suspected of having the capacity to reduce the efficacy of levonorgestrel, according to current SPC, include:

Reference should be made to the Fraser Guidelines if the client is under 16 years, to confirm that these are understood and met. Special consideration should be made regarding child protection issues

If there is any reason why the pharmacist is unable to issue HEC under the terms of the PGD, the client must be referred by the pharmacist to their GP, or to a doctor at the family planning clinic for an urgent appointment.

Step 2: CRITERIA FOR ISSUING

Once the Pharmacist has completed the clinical assessment, and is satisfied that the client needs HEC, that there are no contraindications and that all the necessary information is accurately recorded on the proforma, HEC may be issued.

1. Clearly label the pack of Levonelle 1500 showing the following particulars:

• the patient's name / identifier
• the date of supply
• the directions for use
• the name and address of the location where the supply is made
• the wording, "keep out of reach of children"

1. Provide the client with the relevant “in-house” patient information leaflet, and the Patient Information leaflet (PIL) for Levonelle 1500.

1. It is advisable (but not mandatory) to observe the client taking the dose whilst in the pharmacy. If this is not possible, advise the client to take the dose as soon as possible.

1. Discuss possible side effects such as nausea, temporary disturbance of bleeding pattern and spotting, lower abdominal pain, tender breasts, headache, dizziness and tiredness.That if vomiting occurs within three hours of taking the tablet, the client may be able to obtain a further supply from a Community Pharmacist free of charge. If not, a replacement tablet can be obtained from either their GP practice or a Family Planning Clinic, or if it is Out of Hours, from the A&E department at Solihull hospital (see in-house PIL.).

1. Emphasise that HEC does not provide protection against pregnancy for the rest of the menstrual cycle and recommend the careful use of a barrier method until the next menstrual period.Emphasise that HEC does not offer any protection against sexually transmitted infections and that condoms are the only means of contraception that provide protection against these.

1. Discuss future contraception. If the client is on the combined oral contraceptive pill (COC) or the progestogen-only pill (POP), she should normally be advised to continue taking it as normal or resume it as soon as HEC has been taken. One dose of COC may be missed, if it clashes with the time of taking HEC. In addition a barrier method of contraception should be used in accordance with current guidelines, 7 days extra precautions for COC and 48hrs for POP.

1. Discuss ‘safer sex’ and correct use of condoms. Inform the client that condoms are available free of charge from Solihull GPs, or from the Contraception and Sexual Health Service, if under 25 years. A supply of condoms may be made free of charge, in the interim period, including to clients under 16years.

1. Clients should be advised to visit the family planning clinic or GP in three weeks, to check HEC has been successful and to monitor/discuss ongoing contraception. Especially if:

• The next period is exceptionally short or light, or more than 5 days late
• She experiences significant lower abdominal pain (possible ectopic pregnancy)
• She experiences other concerning side effects

If an older client is confident that the HEC has not failed and is not requiring advice or supplies, she may not need a GP or clinic follow up three weeks later.

Step 3: COMPLETION OF PAPERWORK

Only complete both parts of Box 6 if two tablets of Levonelle 1500 have been supplied.

Issue the dispensed product to the client and ask her if she is willing for you to witness her taking Levonelle 1500 in the Pharmacy.

Detach bottom, anonymised, copy and send to Solihull Care Trust for re-imbursement at the end of each month.

Retain the top copy of proforma securely and confidentially in the Pharmacy.