Westminster

Primary Care Trust

Specification for a locally enhanced service

Provision of Emergency Hormonal Contraception (Levonelle -1500®) by Community Pharmacists for young women aged 13-19 years

2007- 08

Introduction

1.  The provision of emergency hormonal contraceptive (EHC) by Community pharmacists is a priority outlined in the Sexual Health Strategy action plan, Commissioning Strategy Plan and Pharmaceutical Needs Assessment (PNA).

2.  The purpose of this paper is to set out a model for a locally enhanced service for the provision of EHC by community pharmacists.

3.  The scheme will be open to young women aged 13-19 years.

Aims

4.  The purpose of the local enhanced service is to increase access to emergency hormonal contraception (EHC) for young women aged 13-19 years in areas of Queens Park & Paddington and Victoria & Pimlico (Churchill, St James’s and Victoria wards) localities, i.e. those with high unplanned pregnancies/ conceptions.

5.  Reduce the under 18s conception rate. The average teenage conception rate for Westminster for 2001-2003 was 46.6 (rate measured as number of <18 yrs conceptions per 1000 females aged 15-17years). The rates for Queens Park & Paddington and Victoria & Pimlico localities were 77.3 and 63.9 respectively. The national target is to halve the under 18s conception rate by 2010 and set a firmly established downward trend in the under 16s conception rate.

6.  Pharmacists to signpost the availability of other services, thereby increasing numbers of young women accessing regular sexual health and family planning services

7.  To allow a faster response to clients’ needs, without the need to wait to see a doctor

Eligibility Criteria

8.  Pharmacies must fully comply with the service specifications of all Essential Services in the contractual framework.

9.  Pharmacies should be located within Queens Park & Paddington and Victoria & Pimlico (i.e. Churchill, St James’s and Victoria wards only) localities.

Scope of service to be provided

Period of Service

10.  The service will be provided from 15th November 2007 to 18th May 2008 and therefore the payment arrangements under this scheme will apply to this period. This will be reviewed for 2008/09.

Named Pharmacist(s)

11.  This service may only be provided by a named pharmacist, who has completed the required training (12-15) and is authorised to operate under the approved patient group direction (PGD). The named pharmacist(s) must be available at the pharmacy for at least 80% of the opening hours.

12.  In addition, the named pharmacist should have had his/ her CRB check. CRB checks will be facilitated by the PCT.

Training

13.  A training course will be provided by Westminster PCT. Any pharmacist that wishes to provide EHC services must attend the training course.

14.  The training sessions will cover:

·  Patient assessment and history taking

·  PGD training

·  Fraser (formerly Gillick) competence training

·  Duty of Care and Confidentiality

·  Child protection training

·  Record keeping

15.  In addition to the training pharmacists will be required to have completed the Centre for Post Graduate Pharmacy Education’s (CPPE) distance learning package on EHC and submit a record of completion to the PCT prior to providing the service.

16.  On satisfactory completion of the full training programme participants will be issued with a certificate of attendance and their name can be included on the accredited practitioner list for the provision of this service.

Premises

16.  The service can only be provided in an approved pharmacy, which should have a suitable area for consultation with the patient. This may be a quiet area within the shop where privacy can be maintained.

17.  The pharmacy will be required to provide dedicated window space for a window sticker to advertise the availability of the service from that pharmacy, and an appropriately placed poster giving information on contraception and sexual health services and how to access them locally.

Patients

18.  Women aged between 13-19 years will be eligible to receive EHC via this service from a participating pharmacy. Pharmacists will need to ask for proof of identification and the first 4 digits of the patients’ postcode.

19.  If the client is believed to be under 16, the pharmacist must apply the Fraser competence (previously known as Gillick competence). When seeing people under the age of 16 pharmacists are also required to act according to Child Protection Guidelines and Department of Health guidance on confidential sexual health advice and treatment for people aged under 16. The pharmacist should refer to the confidentiality aspect in their opening statement informing the client that:

“the information you give is confidential unless I consider that you or some other young person is at risk of suffering emotional or physical harm. In these exceptional circumstances I have a duty to share this information with other health professionals such as ‘the children and family team at social services’. Hopefully, this can be done with your agreement, but this is not always required.”

If the pharmacist has any concerns relating to a possible need to breach confidentiality for the above reasons, please contact Westminster PCT’s Child Protection Team in the presence of the young person. Do not act in isolation.

20.  When a young person is judged not to be competent in line with the Fraser ruling, she should be referred to the Family Planning Doctor or their GP. If the non-competent young person attends with a parent and both agree to treatment, then Levonelle 1500® can be given and both sign the PGD record sheet.

21.  If the non-competent young person attends with a parent but the young person does not agree to treatment they must be referred to the Family Planning clinic or GP.

22.  The service will be advertised in participating pharmacies, GP practices, family planning clinics and other community pharmacists in Westminster PCT.

Privacy and Confidentiality

23.  Part 2 of the Code of Ethics outlines the pharmacist duty of confidentiality. It states:

“The public expects pharmacists and their staff to respect and protect confidentiality. This duty extends to any information relating to an individual, which pharmacists or their staff acquire in the course of their professional activities. Confidential information includes personal details and medication, both prescribed and not prescribed.”

Payment

24.  A consultation fee of £15 per patient supplied EHC under the PGD will be paid.

25.  Pharmacies will also be reimbursed the trade price for the cost of any Levonelle 1500® supplied. This is £5.11 plus VAT.

Please Note: The OTC product Levonelle One Step® must not be supplied, as the licensing and the patient information leaflets are different. Pharmacists will not be reimbursed for supply of the OTC product.

26.  A payment claim summary form (Appendix X) will be submitted once a month (by the 5th of each month) to Arfana Butt, Community Pharmacy Development Pharmacist. Payment claims received after 3 months from the date of consultation will not be reimbursed.

Supplies

27.  Pharmacies will be required to acquire their own stock of Levonelle 1500® for supply under the LES.

28.  A single pack of Levonelle 1500® can be supplied under the PGD if

·  The pharmacist is satisfied that EHC is appropriate;

·  The pharmacist is satisfied that the client understands the circumstances in which EHC will be effective.

29.  The product may only be supplied for use at the time and should not be supplied for possible future use. Friends, relatives and other third parties may not collect a supply on behalf of the intended user.

Indemnity

30.  The service provider will operate in accordance with all Acts of Parliament, statutory regulations or other such laws, recommendations, guidance or practices as may affect the provision of services specified under the Agreement.

31.  Any litigation resulting from an accident or negligence on behalf of the Provider is the responsibility of the Provider who will meet the costs and any claims for compensation, at no cost to the PCT. The pharmacist must ensure that their professional indemnity insurance provider has confirmed that this activity will be included in their policy.

Record Keeping

32.  Pharmacists must keep records of the consultation and its outcome on the Record Sheet for supply of Levonelle 1500® that has been provided (appendix XX). Ideally records should be kept on the pharmacy computer, via the patient’s medical record.

33.  Client records must be kept by the accredited pharmacy for 8 years (or up to the client’s 26th birthday in the case of clients under 16).

Agreement

34.  Appendix XXX must be completed and returned to the PCT by all pharmacies participating in the LES.

Monitoring and Performance Management Requirements

35.  Pharmacies will provide to the PCT such information as the PCT may reasonably require:

a.  in order to prepare its own accounts for external audit

b.  to comply with any other legal or DH obligation placed on the PCT.

36.  The PCT will routinely audit 5% of claims made by the pharmacy. Pharmacies will therefore be required to keep and maintain full and accurate records of all receipts and payments to the provision of services under this scheme.

Exit and Suspension Arrangements

37.  Suspension

The scheme will be suspended if at any time the pharmacy is unable to provide services in line with the eligibility criteria.

Before any suspension the pharmacy and the PCT will discuss the reasons for the suspension, identifying any possible resolution.

If the matter is not resolved, the PCT will issue an immediate suspension notice to the pharmacy.

38.  Exit Arrangements

Either party can provide 4 weeks notice to exit the scheme.

Before issuing an exit notice, the parties will meet to discuss the reason for termination.

If, after this meeting, the reason for terminating is not resolved, then the relevant party will issue an exit notice.

39.  Appeal

Either party can appeal against a suspension or termination notice to the Primary Care Commissioning Committee Chair (or Vice Chair).

Review

40.  This LES will be reviewed for 2008/09.

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Community Pharmacy Supply of EHC Locally Enhanced Pilot Service 2007/08