Supplementary Information - ellaOne Sexual Health Service ... · Supplementary Information - ellaOne Sexual Health Service ... (SOP) ... Cu-IUD must always be considered as it is

Supplementary Information – ellaOne for NHS Bradford and Airedale Sexual Health (EHC) Service 1

Nov 2012

Supplementary Information - ellaOne

Sexual Health Service (EHC) for

NHS Bradford and Airedale Contact Details: Ruth Buchan Service Development Manager Tel: 07718 192 287 Email: [email protected]

Community Pharmacy West Yorkshire Brooklands Court Tunstall Road Leeds LS11 5HL Tel: 0113 272 7560

Contents

Definitions .................................................................................................................. 2

Key Principles ............................................................................................................ 2

First things First .......................................................................................................... 3

The service ................................................................................................................. 4

Changes to the service ............................................................................................... 4

ellaOne Background Information ................................................................................ 5

Treatment choice and supply ..................................................................................... 6

ellaOne Additional Information ................................................................................... 7

BMI ......................................................................................................................... 7

Drug Interactions .................................................................................................... 7 Mid-cycle or cycle not known .................................................................................. 7

Black Triangle (▼) .................................................................................................. 8 ellaOne patient specific advice ............................................................................... 8

Referral ...................................................................................................................... 8

Support and advice .................................................................................................... 9

Flow chart ................................................................................................................. 10


Nov 2012

Other matters ........................................................................................................... 11

Reimbursement ........................................................................................................ 11

Claims process ......................................................................................................... 11

Standard Operating Procedure (SOP)...................................................................... 11

PGD matters ............................................................................................................ 11

Resources ................................................................................................................ 12

Appendix 1 ............................................................................................................... 16

Self-declaration of Competency to supply ellaOne under the NHS Bradford and

Airedale PGD ........................................................................................................... 16

Version Control

Version No. Changes Applied By Date

1 First draft RB 31 Oct 2012

2 Amended following comments from Robbie Turner and information provided by Jeannette Crabbe

RB 12 Nov 2012

Definitions

BMI Body Mass Index OTC Over-the-counter

CASH Contraception and Sexual Health Service SOP Standard Operating Procedure

Cu-IUD Copper Inter-Uterine Device STI Sexually Transmitted Infection

EHC Emergency Hormonal Contraception UPA ulipristal acetate - ellaOne

LARC Long-Acting Reversible Contraception UPSI Unprotected Sexual Intercourse

LNG Levonogestrel- Levonelle

Key Principles

This information booklet is designed to assist pharmacists providing the NHS Bradford and Airedale Sexual Health Service following the introduction of the ellaOne PGD.

This information booklet is not a comprehensive service guide for the Sexual Health Service and as such it does not contain all the information required in order to provide the service.

This information does not replace the formal contractual arrangement between the pharmacy and the Commissioner to provide the service. Therefore the existing Service Specification and associated paperwork must be read in conjunction with this information.


Nov 2012

First things First

In order to comply with legal requirements each pharmacist who wishes to work under the ellaOne PGD must undertake the following before working under the ellaOne PGD:

Check they are accredited to provide the NHS Bradford and Airedale Sexual Health (EHC) service (Accreditation is proven by possession of a current, expiry dated certificate provided by the NHS Bradford and Airedale).

Ensure they have the correct knowledge required to work under the ellaOne PGD (this is likely to be met by undertaking CPD relevant to the service and ellaOne). Pharmacists must be familiar with the PGD for ellaOne and the Product Licence/ SPC.

Pharmacists must complete self-certification (appendix 1 p16) to state that they have undertaken relevant CPD, are competent to supply a ellaOne in accordance with the Patient Group Direction and understands the clinical, ethical, cultural and legal aspects of supply via a PGD.

Is authorised by name by the PCT to work under the current PGD by carrying out the following in each pharmacy in which they will be working under the ellaOne PGD:

o Sign the pharmacy copy of the PGD o Take a photocopy of the PGD signature sheet and submit this to Jeannette Crabbe at the

PCT

Only provide the service from a pharmacy with a signed agreement (commissioned) to provide the service and working to the terms of the locally enhanced service agreement.

Pharmacists who are currently accredited to provide the Sexual Health (EHC) service currently in NHS Bradford and Airedale do not need to undertake any formal training or accreditation to provide ellaOne under the PGD as ellaOne has been introduced as a service extension to the current service.

For any queries relating to the service contact the service co-ordinator, Jeannette Crabbe or Community Pharmacy West Yorkshire Service Development Manager, Ruth Buchan.

Jeannette Crabbe Young People's Sexual Health Services Specialist

NHS Airedale, Bradford and Leeds Douglas Mill Bowling Old Lane Bradford BD5 7JR Tel 01274 237355 Mob 07852 915 790 E-Mail [email protected]

Ruth Buchan Service Development Manager Community Pharmacy West Yorkshire Brooklands Court Tunstall Road Leeds LS11 5HL Tel: 0113 272 7560 Mob: 07718 192 287 Email: [email protected]

mailto:[email protected]


Nov 2012

The service

Key Point – The pharmacy is providing a Sexual Health Service

Pharmacists and their teams are being commissioned to provide a holistic sexual health service in which supply of EHC forms only a part of this service.

A consultation under the Sexual Health (EHC) service must include:

Being clear about confidentiality with the client

Discussion of all three options for emergency contraception

o Cu-IUD

o ellaOne

o Levonelle

Assessment of the client’s suitability to receive EHC in line with the relevant PGD and service

specification. This may include a pregnancy test.

Supply of EHC (as appropriate)

Consideration of, and if necessary managing, any safeguarding issues

Advice on the avoidance of pregnancy and sexually transmitted infections through safer sex

and condom use (including how to use condoms and a supply of condoms where

appropriate)

Providing information about long-term contraceptive methods including information about

LARCs

Providing details of where and how to access

o services that provide long-term contraceptive methods

o services that provide sexual health advice and STI services (including screening)

o further advice and care

Changes to the service

The only change to be introduced into the service is that pharmacists will have the option of making a supply of ellaOne under a PGD when appropriate for a client.

All other matters, such as the action to take if a client is excluded, signposting, safeguarding, have not changed from the existing service.

The introduction of the ellaOne PDG does not alter the treatment options that must be discussed with every client.


Nov 2012

ellaOne Background Information

The rational for the introduction of the ellaOne PGD is because ellaOne;

allows for the provision of emergency contraception to women who are at risk of unwanted pregnancy and present within 120 hours (5 days) following unprotected sexual intercourse or contraceptive failure (therefore increasing the effectiveness and window of opportunity by 48 hours following unprotected sexual intercourse compared with Levonelle)

More effective than Levonelle in women with BMI> 30

More effective than Levonelle for women presenting in their fertile period

UPSI and oral emergency contraception failure

Glasier et al. Contraception 2011

Fa

ilure

%

Weight and oral emergency contraception failure

Fai

lure

%

Glasier et al. Contraception 2011


Nov 2012

Information within this section has been extracted from the ellaOne Business Case produced by NHS Bradford and Airedale.

Treatment choice and supply

Following discussion with the client of the three options for emergency contraception, their merits, effectiveness and limitations, the pharmacist is to use their professional judgement as to which treatment option(s) are the most appropriate for the client.

Treatment options for emergency contraception; o Cu-IUD o ellaOne o Levonelle

Cu-IUD must always be considered as it is the most effective form of emergency

contraception and can be used up to day 19 of the menstrual cycle.

Once the most appropriate treatment option has been discussed and agreed with the client the pharmacist then must ensure that the supply is made within the specifications of the relevant PGD. Supply must only be made if appropriate.

The flowchart on p10 can be used to assist with the treatment choice.

It is important to note that if Cu-IUD has been chosen by the client a supply of hormonal emergency contraception (Levonelle or ellaOne) must be offered to the client if clinically appropriate. This gives additional protection should the client be lost to follow up (e.g. not make the appointment for the Cu-IUD fitting) or is not be able to have the Cu-IUD fitted.


Nov 2012

ellaOne Additional Information

In summary, ellaOne can be supplied via the PGD in the following circumstances:

Between 72 and 120 hours (days 4-5) post UPSI (Unprotected Sexual Intercourse)

Between 0 and 120 hours after UPSI when the client is mid-cycle (days 13-14)

Between 0 and 120 hours after UPSI when the client is unsure of the day of cycle

Between 0 and 120 hours after UPSI for a client with a BMI greater than 30

The following information is a highlight of the additional matters to be considered when ellaOne is supplied. The ellaOne PGD must be referred to when making an ellaOne supply.

BMI

For clients where the pharmacist suspects that the client may have a BMI of 30 more over they should ask the client for their current weight and height and use this to calculate the clients BMI. Where the client is unable to supply this information the pharmacist should use their professional judgement as to the best course of action. Where validated weighing scales and height chart are available the pharmacist has the option of measuring the patient’s weight and height in the pharmacy.

Drug Interactions

ellaOne has some notable drug interactions which must be considered when selecting treatment choice.

Proton Pump Inhibitors- reduces efficacy; concomitant use not recommended.

Antacids- reduces efficacy; concomitant use not recommended.

H2 Receptor Antagonists- reduces efficacy; concomitant use not recommended.

Hormonal Contraceptives- Ulipristal interferes with the action of progestogen containing medications and concomitant use with levonorgestrel not recommended. Continued use of regular hormonal contraception is not contraindicated but it is recommended that reliable barrier method is used until next menstrual period starts or for the following lengths of time:

Combined hormonal methods ( pill, patch, vaginal ring),Progestogen only Implants, Progestogen only injectables - 14 days.

Progestogen only pills - 9 days

Qlaira contraceptive pill - 16 days

Liver enzyme inducing medication may reduce the effectiveness of ulipristal acetate

Liver Enzyme Inhibitors- ketoconazole, itraconazole, clarithromycin, nefazodone: increase plasma level of ulipristal acetate. Clinical relevance of this is unknown.

Mid-cycle or cycle not known

The consultation must include an assessment of where the client is in her menstrual cycle. For

clients who are mid-cycle (days 13-14) or who are unsure of the date of their last menstrual period,

ellaOne is the treatment choice as it offers a slightly higher efficacy around the time of ovulation

than Levonelle.


Nov 2012

For women on the contraceptive pill the pill-free days should be used to calculate the cycle (not days

of the withdrawal bleed).

Black Triangle (▼)

ellaOne is a Black Triangle product (▼) and all adverse effects should be reported to the Medicines and Healthcare Products Regulatory Agency (MHRA) through the Yellow Card scheme (for details see BNF). Therefore advise patients to report all suspected reactions.

ellaOne patient specific advice

That pregnancy can still occur, despite treatment.

If menstrual periods are delayed by more than 7 days or if periods are abnormal in anyway (light, heavy or painful), the patient should seek medical advice.

To seek medical advice if there is any lower abdominal pain

That if a pregnancy has occurred, following failure of Ulipristal treament, she should contact GP/CASH clinic for follow-up to ensure that it is not ectopic

Of the need to use a reliable barrier method as specified under Drug Interactions or until the next menstrual period (or abstain from sexual intercourse). This should be emphasised strongly.

Referral

Clients presenting for emergency contraception but who are excluded from the EHC PGD criteria will be referred 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. age range.

When a referral is made the the pharmacist should make every effort to contact the GP/ CaSH clinic to book an appointment for the client and inform the client of the time and location of the appointment. Taking this active approach reduces the chance that a client will be lost to follow up.

If the accredited pharmacist is not available to supply emergency contraception the pharmacy has the option of making a referral to another pharmacy. In these circumstances the pharmacy to which the client is being referred must be contacted to check that an accredited pharmacist will be available to provide the Sexual Health (EHC) Service for the client.

Taking an active approach to referrals reduces the chance that a client will be ‘lost to follow up’.

This could make the difference between an unintended pregnancy or not.

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.


Nov 2012

Support and advice

If you are not sure of any aspect regarding the sexual health service or supply of EHC, the pharmacist can seek advice from CASH clinic. If advice is required outside of CASH opening hours then pharmacists can consider contacting local GP or LCD.

The Safeguarding Children's Team can be contacted to discuss any concerns relating to child protection.

Comprehensive information can be accessed at: http://www.bradford-scb.org.uk/

Bradford Safeguarding Children Board If you have concern that a child is being harmed as a result of abuse or neglect, you

must not keep these concerns to yourself.

KEEPING CHILDREN SAFE IS EVERYONE'S RESPONSIBILITY. In the Bradford district, these are the numbers that you can ring for advice and to make a referral:

If you have reason to believe that a child is at IMMEDIATE RISK OF HARM, contact the

police on 999

During office hours call Children's Social Services Initial Contact Point - 01274 437500 - (8.30 to 5pm Monday to Thursday, 8.30 to 4.30 on Friday)

At all other times, Social Services Emergency Duty Team - 01274 431010

You need to ensure that you speak to the appropriate organisations who can listen to and record your concern, and then take appropriate action.

http://www.bradford-scb.org.uk/


Nov 2012

Flow chart


Nov 2012

Other matters

The supply of ellaOne will be made free of charge to the client at NHS expense.

The pharmacist supervises the client taking the ellaOne tablet.

Reimbursement

A fee of £10 will be paid per sexual health consultation, irrespective of whether or not medication is

supplied, plus the cost of reimbursement of Levonorgestrel 1500mcg tablet (Levonelle POM, £6) or

Ulipristal Acetate (ellaOne, £16.95) and pregnancy testing kits according to current trade price plus

VAT.

Claims process

The process for submitting claims remains the same. Claims will be made by submitting the claims

summary sheet at the end of every calendar month to:

Bradford Teaching Hospitals NHS Foundation Trust RAE 4405 Phoenix House Topcliffe Lane Tingley Wakefield WF3 1WE

Standard Operating Procedure (SOP)

Each pharmacy contractor should produce a Standard Operating Procedure (SOP) for each enhanced service.

Following the introduction of the ellaOne PGD the pharmacy may need to review the Sexual Health (EHC) service SOP.

SOPs demonstrate that the pharmacy is providing safe and effective services which meet the requirements of the commissioned service.

PGD matters

This service is underpinned by two PGDs which can be accessed from: http://www.lpc-online.org.uk/bradford_airedale_lpc/ehc.html

Supply of Levonorgestrel Emergency Hormonal Contraception (EHC) from Community

Pharmacies

Supply of Ulipristal Acetate Tablets 30mg Emergency Hormonal Contraception (EHC) From

Community Pharmacies

http://www.lpc-online.org.uk/bradford_airedale_lpc/ehc.html



Nov 2012

When working under any PGD the pharmacist must be familiar with the content and limitations of the PGD and work within these at all times.

Pharmacists must ensure that they are working within the relevant, in-date PGD. Different organisations PGDs will differ and PGDs will be amended in each version.

Pharmacists must be familiar and competent in the use of PGDs. A Patient Group Direction- Information Sheet is available from (http://www.lpc-online.org.uk/bradford_airedale_lpc/ehc.html).

Clients excluded from the PGD criteria will be referred to another local service that will be able to assist them, as soon as possible, e.g. GP, CASH, or will be invited to purchase the Pharmacy medicine product if the exclusion from supply via the PGD is due to age.

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.

Resources

Product Description

Order from

The Emergency Hormonal Contraception form (amended to include ellaOne supply)

Jeannette Crabbe

NHS Airedale, Bradford and Leeds Douglas Mill Bowling Old Lane Bradford BD5 7JR E-Mail [email protected] Alternatively forms can be downloaded from: http://www.lpc-online.org.uk/bradford_airedale_lpc/ehc.html

Invoice template

Sent to pharmacies by Jeannette Crabbe on signing up to the service






Nov 2012

Product Description

Order from

Information Leaflet

FPA Contraceptive Choices

Lynfield Mount Library and Health Promotional Resources, Tel 01274 363194

Information Leaflet

Chlamydia


Information Leaflet

Your sexual health – where to go for help and advice


Information Leaflet

Further sexual health

resources can be ordered.

Contact Lynfield Mount

Health Promotion Resource

centre for further details


Talking to young people

Download from http://www.lpc-online.org.uk/bradford_airedale_lpc/ehc.html




Nov 2012

Product Description

Order from

Fraser Guidelines guide


Service Specification


Patient Group Direction

A copy should be available in the pharmacy which is signed by every pharmacist working under the PGD

Condoms

[email protected]

Tel- 01274 221073 (Part-time only)

Pregnancy tests

[email protected]

Tel- 01274 221073 (Part-time only)








Nov 2012

Product Description

Order from

Signposting information


Signposting information - Safeguarding


Pharmacy-based Sexual Health Service Consultation A4 sheet








Nov 2012

Appendix 1 Self-declaration of Competency to supply ellaOne under the NHS Bradford and Airedale PGD Each individual pharmacist is responsible to ensure that they maintain competency to supply

medication under a PGD. This self-declaration form may be used by pharmacists to demonstrate the

activities they have undertaken and to provide a statement to the commissioner of the service that

they are competent to provide ellaOne under the NHS Bradford and Airedale PGD.

The pharmacist should work through this form, reflect on the issues raised, comment on any actions

required and sign the declaration at the end of the form.

Enhanced service being delivered: NHS Bradford and Airedale ellaOne PGD being delivered as part of the Sexual Health (EHC) Service

Statement Yes No Comments

1 I have read the ellaOne PGD and am familiar with the content and limitations of the PGD and understand that I must work within these at all times. Date read PGD:

2 I understand the clinical, ethical, cultural and legal aspects of supply via a PGD.

3 I understand that I am liable and professionally accountable for any supply made under the PGD.

4 I have undertaken the following CPD, training courses or programmes which are relevant to this enhanced service and specifically ellaOne List the CPD and courses here with approximate dates:

5 I have reviewed the service documentation for the provision of this enhanced service (e.g. service specification, paperwork, PGD etc) and I confirm that I have implemented any necessary changes in service delivery.

6 I understand that I must follow the service specification and additional information associated with the service provided by the PCT.

7 I have revisited the Standard Operating Procedures I have in place within the pharmacy to support the delivery of this service.

8 I have undertaken training / development with the pharmacy team to update them on this enhanced service.

Signed GPhC number

Print name Date


Nov 2012

Self-declaration of Competency to supply ellaOne under the NHS Bradford and Airedale PGD

I declare that I am competent provide ellaOne under the PGD as part of the

NHS Bradford and Airedale Sexual Health (EHC) service.

Signed GPhC number

Print name Date

Job title (locum, pharmacy manager etc)

Contact

Address

(pharmacy address or in the case of locum home address)

Contact email

Mobile number

This self-declaration does not remove inherent professional obligations or accountability. It

is the responsibility of each professional to practice only within the bounds of their own

competence and in accordance with their own code of professional conduct.

Documents

Supplementary Information - ellaOne Sexual Health Service ... · Supplementary Information - ellaOne Sexual Health Service ... (SOP) ... Cu-IUD must always be considered as it is