Agreement for the Provision of a Enhanced Pharmaceutical Services with Bexley Care Trust

BEXLEY CARE TRUST

Agreement for the provision of a Enhanced Pharmaceutical Services with Bexley Care Trust

Emergency Hormonal Contraception

1.Introduction

1.1.This Service Agreement is between Bexley Care Trust and the Contracting Pharmacist detailed in section 2.1 for the provision of the Enhanced Pharmaceutical Service Emergency Hormonal Contraception within Bexley Care Trust and replaces any previous agreement.

1.2.The contract remains effective for 12 months from 1st April 2006 unless there is need for early termination as set out in Section 9.

1.3.The service will be provided in accordance with the Emergency Hormonal Contraception Patient Group Direction attached at Appendix A.

1.4.Bexley Care Trust may limit the number of clients that the contracting pharmacist be allowed to supply within the scope of the service

2.Parties to the Agreement

2.1.This agreement is between Bexley Care Trust and the following Contracting Pharmacist:

Name of Contracting Pharmacist:

2.2.The pharmacist shown in 2.1 will be responsible for providing the service described herewith. Bexley Care Trust, at its absolute discretion, may allow other pharmacists to undertake the work on the contracting pharmacist’s behalf provided that the training requirements detailed in 3.4 have been met and that agreement has been obtained from the Principal Prescribing Advisor of Bexley Care Trust in advance. The pharmacist shown in 2.1 will remain accountable for the provision of the service.

3.General Conditions

3.1.Client Group: The service will be available to any patient who is in need of the service and meets the criteria set out in the Emergency Hormonal Contraception Patient Group Direction.

3.2.The Service Provider: The service will only be provided by Community Pharmacists who have undertaken the training detailed in 3.5.

3.3.Service Specifications: The service will be provided in accordance with the service specifications for Emergency Hormonal Contraception(as described in the PGD at Appendix A).

3.4.Co-ordination: Bexley Care Trust are responsible for the co-ordination of the service across the Trust. Any queries regarding the service should be directed to the Principal Prescribing Advisor of Bexley Care Trust.

3.5.Training: The Contracting Pharmacist signing this agreement and any Pharmacist providing the service on their behalf will need to have completed the training listed below.

1. Attend training evening on Thursday 16th February 2006
2. To complete a Criminal Records Bureau Disclosure form and contact HR department for document verification by 28th February 2006
3. Complete the CPPE distance learning pack titled Emergency Hormonal Contraception and send a copy of the confirmation certificate to the Principal Prescribing Advisor by 17th March 2006

3.6.Patient Information: Adequate information and opportunity should be provided so that the patient understands the service. This is expected to comprise appropriate information on:

• the purpose, and expected benefits of the service and the related treatments
• the nature, action and effects of drugs they are taking
• safe storage and handling of medicines

4.Patient Confidentiality

4.1.All information collected regarding patients is strictly confidential. Any records kept must comply with the Data Protection Act, and Access to Health Records Act, 1990. Patient Confidentiality must be maintained as per NHS guidance.

5.Insurance

5.1.The Contracting Pharmacist is responsible for securing appropriate indemnity cover for provision of the service including that required for all staff that are employed in its function.

6.Finance

6.1.Payment of the Community Pharmacists will be calculated according to number of Levonelle packs supplied with a total payment of £30 per supply.

6.2.Invoices will be submitted on a monthly basis for those services provided in the preceding month. Invoices must be submitted by the 5th day of the month following that in which the service was provided. The procedure for submission of documentation for payment must be followed (Appendix B). Late claims may not be processed.

7.Monitoring Audit and Evaluation of the Service

7.1.This service will be monitored and evaluated by Bexley Care Trust, using the documentation submitted by the pharmacist.

7.2.Any comments regarding the service should be directed to the Principal Prescribing Advisor for Bexley Care Trust.

7.3.A representative of Bexley Care Trust may wish to visit the pharmacist to monitor progress. Arrangements to do so will be made in advance.

8.In the Event of a Dispute

8.1.In the event of a dispute regarding the provision of the service, the matter will be referred to the Principal Prescribing Advisor for Bexley Care Trust. If it remains unresolved, it will be referred to the Chief Executive of Bexley Care Trust for further action.

9.Termination

9.1.This agreement may be terminated by Bexley Care Trust by giving 28 days notice in writing to the Contracting Pharmacist at any time in the event of:

9.1.1.the pharmacist ceasing or threatening to cease to carry out all or any part of its undertaking as constituted at the start date.

9.1.2.the pharmacist being in breach of any obligations on their part under this agreement, after prior notice from Bexley Care Trust to the pharmacist of such breach giving the pharmacist a reasonable opportunity to remedy it if capable of remedy.

9.2.This agreement may be terminated by the pharmacist by giving 28 days notice in writing to Bexley Care Trust if the PCT is in breach of any obligation on its part as agreed at the start date, after prior notice from the pharmacist to Bexley Care Trust of such breach giving the Trust a reasonable opportunity to remedy it if capable of remedy.

9.3.Termination of this agreement, whether by expiry or early determination, shall be without prejudice to any rights of either party against the other which may have accrued up to the date of termination or are capable of surviving termination including, without limitation, any provisions relating to any quarter or any accounting year, or part thereof, ending on or prior to the date of termination.

9.4.On termination of an agreement, either by Bexley Care Trust or the Contracting Pharmacist, any materials associated with the service must be returned to the Principal Prescribing Advisor for Bexley Care Trust if requested.

Signed:

Principal Prescribing Advisor for Bexley Care Trust:

Appendix A: Conditions of Patient Group Direction

Title: SUPPLY of LEVONELLE 1500microgram (EMERGENCY HORMONAL CONTRACEPTION) by PHARMACISTS

1.CLINICAL CONDITION

1.1Define situation/condition

Provision of Emergency Hormonal Contraception (EHC) when a client presents within 72 hours of unprotected sexual intercourse (including failure of existing method of contraception).

Following missed oral contraceptive pill(s), give advice or EHC in line with Summary of Product Characteristics of the relevant pill.

1.2Criteria for inclusion

Clients 14 years and over

(This is outside the licensed age range for Levonelle 1500microgram.)

1.3Consent

If the client is under the age of 16 years, the pharmacist must establishcompetence using the ‘Fraser Ruling Guidance’ and encourage the young person to discuss the situation with their parents if possible. See Appendix 1

Document competency in the consent form, EHC1. (Appendix 2)

1.4Criteria for exclusion or referral to a Doctor

a)Unprotected sexual intercourse over 72 hours ago

b)History of any other episode of unprotected sexual intercourse earlier in the same cycle

c)Pregnancy

d)Unexplained vaginal bleeding

e)Known hypersensitivity to Levonorgestrel or its excipients

f)Current breast cancer

g)Severe liver disease or hepatic dysfunction

h)Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.

i)Currently on any of the following enzyme inducing drugs such as barbiturates; antiepileptics such as carbamazepine and phenytoin; antituberculous therapy such as rifamipicin; herbal medicines such as St. John’s Wort ; and antivirals such as ritonavir; antifungal drugs such as griseofulvin. (Check for other drug interactions in the latest BNF, for example cyclosporin: levonorgestrel may increase cyclosporin toxicity).

j) Malabsorption syndromes such as Crohn’s Disease or current severe diarrhoea or vomiting.

1.4Action if excluded

If more than 72 hrs but less than 120 hrs have elapsed, the intrauterine contraceptive device (IUCD) should be considered as a method and discussed with the client. Refer client to a Family Planning Clinic where a doctor or nurse is qualified to fit IUCD, if the client wishes to consider this option. List of Family Planning Clinics in Bexley is listed on the Bexley Care Trust “Wise Up” leaflet.

Advise client to go to a Family Planning clinic in three weeks for a follow up appointment

Advise client to use condoms until their next period.

1.5Action if patient declines

Advise regarding possibility of pregnancy

Advise to return to a Family Planning Clinic in three weeks for a follow up appointment.

Advise client to use condoms until their next period.

2.DESCRIPTION OF TREATMENT

2.1Name of medicine

Levonelle 1500microgram (Levonorgestrel 1500 micrograms)

2.2POM/P/GSL

POM

2.3Dose

One tablet

2.4Frequency

If client presents for further tablets within same menstrual cycle refer to a doctor. The only exception is where the client has vomited within 3 hours after taking the tablet. See section 2.7

Not recommended as a regular method of contraception

2.5Restrictions on the quantity of medicine that may be supplied on any one occasion

One tablet

2.6Route of administration

Orally. Once only in each menstrual cycle.

The client should be reminded that this is not recommended at a regular method of contraception.

2.7 Restriction on the number of supplies

The pharmacist may make a second supply within the same menstrual cycle only if

• the client has vomited within 3 hours of taking the tablet and
• providing the replacement dose is still within 72 hours of the first unprotected intercourse.

If the replacement dose is later than 72 hours post unprotected intercourse, a referral for an IUD may be indicated.

2.8 Minimum or maximum period of administration of medicine

The tablet must be taken within 72 hours of unprotected intercourse.

2.9Advice given to patient

The patient should take the tablet on the pharmacy premises, preferably with a snack.

If vomiting occurs within 3 hours of taking the tablet, contact the supplying pharmacy or other pharmacy in the EHC scheme (appendix 3) or the nearest A&E department, if the supplying pharmacy is shut, for the replacement dose.

If the client experiences any unusual symptoms, including abdominal pain, she should seek medical advice.

Emergency hormonal contraception does not provide protection against pregnancy for the rest of the menstrual cycle. Other contraceptive methods will be needed. Advise the client to use a barrier method of contraception, for example, condoms, for the rest of the cycle.

If a client receives EHC following missed pill(s), advise her to attend a Family Planning clinic without delay.

If client experiences any unusual symptoms including abdominal pains medical advice should be sought

Inform client of following:-

Mode of action- Levonorgestrel is thought to work by preventing ovulation and fertilisation. It is thought to make the lining of the womb unsuitable for implantation. It acts before pregnancy has begun.

Efficacy- It has been estimated that levonorgestrel taken as two 750micrograms tablets prevents 95% of expected pregnancies if used within 24 hours and 85% if used within 24 to 48 hours. The earlier in the 72 hours period the first dose is given, the greater the efficacy.

If there has been unprotected sexual intercourse more than 72 hours earlier in the same menstrual cycle, conception may already have occurred and treatment with levonorgestrel 1500 micrograms may therefore be ineffective in preventing pregnancy.

Foetal effects-There is no evidence to date that this method of emergency contraception has teratogenic effects on the foetus. However, a normal outcome to any pregnancy cannot be guaranteed. Every woman has a 1 in 50 chance of foetal abnormality.

Menstrual cycle-There may be a possibility of a disruption to the normal menstrual cycle. It can alter the timing of the next menstrual period which may be early or late, usually within 3 days of the expected time. If menstrual period is delayed by more than 3 weeks, pregnancy should be excluded.

Breast feeding- A small amount of levonorgestrel is secreted into breast milk. It is not thought to be harmful. However, to minimise exposure of the baby, breast-feeding should take place before taking the tablet.

Sexually transmitted diseases (STI)- Levonelle 1500microgram offers no protection against STI.

Emphasise that these tablets are for emergency use only and not as a regular method of contraception because it is not effective for regular contraception.

Advise client to visit a Family Planning Clinic or General Practitioner for regular method of contraception.

Advise to use extra method of contraception e.g. condom for the remainder of the cycle.

Provide Bexley Care Trust “Wise up” leaflet for youth advisory clinics and family planning clinics.

2.10Follow up action

Advise client to return to General Practitioner or Family Planning Clinic nurse in three weeks.

If the client has not had a period in these three weeks, request that they bring an early morning specimen of urine for pregnancy testing.

2.11Records of supply or administration of medicine

Complete proforma EHC1 (appendix 2) for all clients

Record name of client and date and time Levonelle 1500microgram given.

All emergency contraception must be supplied personally by the pharmacist and must be labelled with

1. The pharmacy address
2. “Keep out of the reach of children”. This is printed on the pack and must not be obscured.
3. The name of the patient and date of supply

The names of pharmacists supplying emergency contraception under this patient group direction will be kept by the Principal Pharmaceutical Adviser, Bexley Care Trust

2.12Potential adverse reactions/warnings

Some clients may experience, nausea and vomiting, breast tenderness, headaches, dizziness and fatigue.

3.CHARACTERISTICS OF STAFF

Pharmacist registered with the Royal Pharmaceutical Society of Great Britain (RPSGB) as a practising pharmacist.

He or she must have completed the CPPE distance learning course of emergency contraception.

He or she must have attended a Bexley Care Trust Emergency Hormonal Contraception seminar.

Appendix 1 of PGD

GUIDELINES FOR ASSESSING A YOUNG PERSON’S COMPETENCE TO CONSENT TO TREATMENT

These guidelines should be used when a young person under the age of 16 years wishes to self-consent to treatment.

1.Parental involvement should be encouraged at all times

2.Discuss all issues fully with the client and answer any questions

3.Client should have the opportunity to read the information sheet and any manufacturers sheets prior to consenting.

4.Ensure the young person is consenting to treatment of their own free will and not being pressurised by anyone else.

5.Each pharmacist is accountable for their own practice and will make the decision regarding the treatment based on the information presented on the day.

6.The pharmacist needs to ensure that the young person has

• Capacity for understanding and communication*
• Ability to engage in reasoning**
• To be in possession of a set of values***

(Ethics and Nursing Practice 1992 Chadwick and Todd, Macmillan Press Ltd)

7.Follow guidance as given in the ‘Fraser Ruling’ (Lord Fraser - Gillick v West Norfolk and Wisbech Area Health Authority 1985

• Contraceptive advise and treatment can be given to a young person without parental consent providing that the following are satisfied:
• The young person will understand the advice
• The young person can not be persuaded to tell their parents or allow others to tell them that they are seeking contraceptive advice
• The young person is likely to begin or continue having unprotected sex with or without contraceptive treatment
• The young person’s physical or mental health is likely to suffer unless they receive contraceptive advice or treatment
• It is in the young person’s best interests to give contraceptive advice or treatment

8. A young person, aged 14 to 15 years, must complete the consent form EHCl in the presence of the pharmacist.

9.4.1.Reference

Ethics and Nursing Practice 1992 Ethics and Nursing Practice 1992 Page 101, Chadwick and Todd, Macmillan Press Ltd

*Capacity for understanding and communication of information which demands that the child must have the cognitive abilities needed to understand language and concepts relevant to the decision. They should have sufficient life experience to appreciate what it might be like to be in a particular state or to experience certain conditions.

**Ability to engage in reasoning which involves making inferences and comparisons as well as weighing and considering the probability of different outcomes.

*** To be in possession of a set of values which, when applied to the situation, will enable evaluation of the various benefits and risks.

9.4.2.Appendix 2 of PGD

ASSESSMENT AND CONSENT FORM FOR THE ISSUE OF LEVONELLE 1500microgram (EHC1)

Client name………………………………………Age………………. DOB…………

Date of request………………………………….Time……………….

Number of hours since unprotected sexual intercourse…………………

If the client answers ‘yes’ to any of the following, do not issue Levonelle 1500microgram. Refer to a doctor at a Family Planning clinic.

a)Have you had unprotected sexual intercourse over 72 hours ago?

b)Have you had unprotected sexual intercourse earlier in the same menstrual cycle?

c)Are you or do you think you are pregnant?

d)Was your last period more than 4 weeks ago?

e)Was your last period in anyway unusual, lighter or heavier than normal?

f)Have you breast cancer or liver disease?

g)Are you taking any other medicines which might interfere with the absorption of Levonelle-2 (refer to the PGD for drugs which interact)?

h)Do you have Crohn’s disease or any other bowel condition which would affect the absorption of Levonelle 1500microgram?

i)Are you under 14 years old?

Discussed:

Method of administration

Action if vomiting occurs

Sexually transmitted disease