London Sexual Health Programme

PGDs

PROCESS FOR DEVELOPMENT, REVIEW, APPROVAL AND IMPLEMENTATION OF PAN LONDON PATIENT GROUP DIRECTIONS IN SEXUAL HEALTH

Background

The preferred way for individuals to receive medicines is for prescribers to provide care on a one-to-one basis. Patient Group Directions (PGDs) allow named registered healthcare professionals to supply and / or administer medicines to groups of patients that fit the criteria laid out in the PGD.

The use of PGDs has improved access to medicines in many services. They have been a really positive move for contraceptive and sexual health service users, reducing time spent in clinic and utilising the skills of nurses and in some PCTs, community pharmacists.

Currently London PCT’s, Trusts and independent organisations have separate PGDs for the supply and administration of contraceptives, and for the treatment of common sexually transmitted infections (STI’s). Inclusions and exclusions, clinical content and presentation varies across London. This potentially leads to a variation in clinical practice.

Those authorised to work to the PGDs are often required to work to many different versions and this has proved problematic particularly for nurses who are often required to work to many PGDs if they have several employers. New PCT cluster arrangements and changing organisational landscapes are adding to these complexities.

This document outlines the formal process to prepare a set of PGD templates to standardise the PGDs across London. This work is initially focussing on PGDs used by nurses in contraceptive and sexual health services for NHS and NHS commissioned independent sector providers. It does not include PGDs for community pharmacists or practice nurses.

It is hoped that by sharing these templates, improved and consistent standards of practice will be achieved to provide a safer, more accessible and more effective service to users and are a key facilitator for service configuration.

Aim

To support delivery of consistent standards of care in sexual health by the development of clinically comprehensive template PGD’s for contraceptive methods and for the treatment of common sexually transmitted infections (STI’s) for implementation across London.

1. Pan London Sexual Health Programme (PLSHP) PGD Project

1.1 Membership

A working group representing stakeholders consists of the following:

Medical consultants from contraceptive and sexual health services
Senior nurses from contraceptive and sexual health services
Pharmacists with a specialist interest and knowledge of contraceptive and/or sexual health.
Pharmacists with expertise and experience in legal and governance aspects of PGDs and/or commissioning.
LSHP lead Hong Tan
LSHP Kathy French, nurse advisor
Commissioners from London
Representation from NHS London

Terms of Reference and a full list of members are available on request.

1. 2 Agreed actions

Development of a suite of Pan London PGD templates for contraceptive methods and treatment of common sexually transmitted infections (STIs) for implementation across London by all NHS Sexual Health Service Providers including those commissioned from the independent sector.
The work initially focuses on PGDs used by nurses in contraceptive and sexual health services for NHS and NHS commissioned independent sector providers. It does not include PGDs for community pharmacists or practice nurses.
Sub-groups of relevant experts consisting of medical, nursing and pharmacist colleagues with the appropriate skills develop and review agreed PGDs using an agreed standard template and format.
Support with communication and consultation with colleagues across London within agreed timeframes for development, review and implementation.

2. Template Development

The development process ensured that:

the PGD is legal and accurate.
the PGD framework for the supply and/or administration of the medicine is safe.
the PGD content is clinically accurate and according to current best practice.

A standard blank PGD template was used for all of the following PGD templates:

Contraception PGD Suite:

Combined Oral Contraceptives (COC)
Progestogen Only Pill (POP)
Combined contraceptive transdermal patch (CTP)
Combined contraceptive vaginal ring
Subdermal contraceptive implant
Intrauterine System (IUS)
Norethisterone Enantate injection
Ulipristal Acetate (emergency contraception)
Levonorgestrel (emergency contraception)
Medroxprogesterone acetate injection
Lidocaine –local anaesthetic for the insertion of subdermal implants

Sexually Transmitted Infections (STI) PGD Suite

Chlamydia
Gonorrhoea
Genital Herpes
Genital Warts
Candida (non STI)
Bacterial vaginosis
Trichomonas vaginalis

Using the agreed blank template, the PGD sub-group have developed each PGD in accordance with:

current best practice.
relevant Medicines Act legislation and related national PGD guidance. Link to
relevant national guidance e.g. UKMEC/ FSRH/ BASHH at www.fsrh.org and www.bashh.org.uk
the most recent reference sources available at the time of writing e.g. manufacturer’s Summary of Product Characteristics (SPC)/ British National Formulary (BNF).
Note : where national guidance dictates that a medicine must be used outside of licence (“off-label”) this information is used and the PGD makes relevant references to this.

The PGD does not include specific training and competencies assessment requirements for practitioners as this also currently varies across London. A recommended training and competencies framework may be developed separately but is not part of this process.

Consultation is aimed to ensure comprehensive communication and opportunity for review of drafts.

The following pharmacy networks were given the opportunity to review the PGDs:

Community Health Services Pharmacists in NHS London
Acute Trust Chief Pharmacists in NHS London
PCT Lead Pharmacists in NHS London
Specialist Pharmacist networks i.e. SWAGNET, South East London HIV and SH Network Board.

The following medical and nursing networks were given the opportunity to review the PGDs:

The lead doctors group for contraceptive and sexual health services
The lead nurses group in London covering contraceptive and sexual health services as well as Brook, Terrence Higgins Trust and Marie Stopes.

Additionally the Commissioning Networks for London were updated monthly on the development of the PGDs.

A nominated lead for each PGD sub-group ensured that all comments for circulated drafts were considered and PGDs amended, ensuring document and version control at all times. All reviewers were notified about any specific changes made or provided with an explanation if comments were not addressed. A record was kept of all correspondence.

3. Template ratification by PLSHP and organisational approval.

The PGD templates were developed and reviewed according to the above process and ratified by a designated Expert Panel for that suite of PGDs as being accurate and fit for purpose. Each PGD template is allocated a Version Number and expiry date.

The London Sexual Health Programme is not a legal authority for the approval of PGDs.

Therefore each organisation must formally approve each PGD template that it wishes to adopt. This includes signatures by a relevant doctor, pharmacist, lead practitioner and clinical governance lead on behalf of the organisation, as set out in PGD legislation. The PGD is not legal or valid without this local, formal authorisation.

Organisations must also add individual authorisations agreements or lists of approved practitioners.

See PGD website FAQ “Responsibilities of signatories”

To ensure that project aims are met, clinical content may not be changed, but organisations can add relevant appendices such as training/competency documents. In addition, where relevant, organisations can append the choice of products to be supplied / administered that has been agreed at local level e.g. selection of oral contraceptive brand.

It is understood that some organisations may not wish to adopt every PGD due to local formulary restrictions e.g. Ulipristal.

4. Implementation

Commissioners may wish to check that organisations have adopted these PGDs as they are a key facilitator for changes in contraception and sexual health services.

They may wish to note this as an activity to be added and then regularly monitored at Quality meetings for providers. This will help deliver improved and consistent standards of practice and provide a safer, more accessible and more effective service to users.

This will also reduce the duplication of effort required for development of PGDs in each organisation thus improve efficiency.

Organisations are encouraged to inform London Sexual Health Programme and their commissioners that they have adopted the PGDs for their services. This will help map and record the effectiveness of the project in achieving the aim of Pan London PGDs for these services.

Individual practitioners must be authorised to practice under the PGD by each organisation within which they work. This is a legal requirement.

Clinical governance and audit surrounding PGD use are local responsibilities.

5. Review

A nominated Project Lead from the London Sexual Health Programme is responsible for ensuring regular review and update/maintenance of the PGDs. Each PGD sub-group (Contraception and STIs) will meet at six month intervals to discuss matters arising e.g. feedback, national guidelines changes, medicines changes and decide whether amendments to the PGDs are required. Meetings may be called earlier if significant changes to practice are required. All PGDs must be formally reviewed and re-ratified no later than three months before the expiry date.

OTHER INFORMATION AVAILABLE ON REQUEST

Project record
Lists of committee members
List of PGD sub-group members
Comments list and response/action
List of approved PGDs/ version/expiry date/review date i.e. 6 months before expiry
List of peer reviewers for each PGD

CONTRACEPTIVE PGDs

Please follow these links to view the Contraceptive PGDs

A STATMENT ON LEVONELLE TIME FRAMES

Since the publication of the LSHP Patient Group Direction (PGD) for supply of Levonelle, we have had some communication with colleagues in the services regarding timeframes for supply up to 120 hours and discussion about evidence to support this. From feedback, it is clear that there are differing local practices with reference to the timeframe within which a patient may be excluded from supply of Levonelle. Some services have access to Uliprisal (ellaOne) and may be using that preparation if the individual presents after 72 hours. Others may not have this on their formulary.

The LSHP Expert Panel who developed the PGDs and who agreed 120 hours, did so with the expectation that the decision to use one preparation over another is a local one, based on local guidelines/formulary and availability of skilled staff to insert an emergency IUD. What we did not want was women denied access to Levonelle after 72 hours in the absence of another choice of treatment or in absence of timely availability of medical referral.

Therefore, we would suggest that it may be a local decision to amend the timeframes within the Levonelle PGD to reflect local guidelines and formulary to ensure that individuals receive the standards of care consistent with FSRH guidelines for emergency contraception 2012 available at http://www.fsrh.org/

Patient Group Direction (PGD) for the supply of emergency hormonal contraception(EHC) by community pharamacists

This PGD template was developed and reviewed according to a robust process and ratified by a designated Expert Panel as being accurate and fit for purpose. Each PGD template is allocated a version number and expiry date. To meet the aim of providing consistent standards of care, we would request that the clinical content of the PGDs is not changed and to contact us directly if you require further clarification.

London Sexual Health Programme (LSHP) is not a legal authority for the approval of PGDs (2). Therefore each organisation must formally approve each PGD template that it wishes to adopt. This includes signatures by a relevant doctor, pharmacist, lead practitioner and clinical governance lead on behalf of the commissioning NHS organisation, as set out in PGD legislation. The PGD is not legal or valid without this local, formal authorisation. Further information and guidance about PGDs can be found on the Patient Group Directions Website (3,4)

Organisations must also add individual authorisations agreements or lists of approved practitioners. Individual practitioners must be authorised to practice under the PGD by each organisation within which they work. This is a legal requirement. Clinical governance and audit surrounding PGD use are local responsibilities.

The expert panel will remain as a virtual network in order to ensure that the PGDs are updated in a timely manner to reflect any necessary changes e.g. national guidance and for formal review of the PGDs about six months before they are due to expire. We would encourage you to inform the London Sexual Health Programme that you have adopted the PGDs for your services. This will help map and record the effectiveness of the project in achieving the aim to support delivery of consistent standards of care in sexual health across London and will help us maintain a database of contacts for future reference.

The panel is also developing a similar PGD for Ulipristal, however it is not yet ready for circulation. We are unable to give a firm timeframe for the completion of it, but if any PCT is developing a service for community pharmacists to provide Ulipristal we would welcome hearing from you.

Click here to view the PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLYOF PROGESTOGEN ONLY EMERGENCY CONTRACEPTION (POEC) (Levonorgestrel 1.5mg) BY COMMUNITY PHARMACISTS WORKING IN A PHARMACY THAT IS EITHER ON A PCT LIST OR IS OPERATING AS AN LPS PHARMACY

Patient Group Directions (PGDs) for the treatment of STI's

These PGD templates for STIs were developed and reviewed according to a robust process and ratified by a designated Expert Panel as being accurate and fit for purpose. Each PGD template is allocated a version number and expiry date. To ensure that project aims are met, clinical content may not be changed, but organisations can add relevant appendices such as training/competency documents. In addition, where relevant, organisations may wish to add their own appendices with reference to local protcols and guidelines for product selection. Do contact us directly if you require further clarification.

London Sexual Health Programme (LSHP) is not a legal authority for the approval of PGDs (2) . Therefore each organisation must formally approve each PGD template that it wishes to adopt. This includes signatures by a relevant doctor, pharmacist, lead practitioner and clinical governance lead on behalf of the organisation, as set out in PGD legislation. The PGD is not legal or valid without this local, formal authorisation. Independent providers should ensure that the correct legal authority is obtained, depending on whether they may or may not authorise their own PGDs. (3,4) Further information and guidance about PGDs can be found on the Patient Group Directions Website (5)

Organisations must also add individual authorisations agreements or lists of approved practitioners. Individual practitioners must be authorised to practice under the PGD by each organisation within which they work. This is a legal requirement. Clinical governance and audit surrounding PGD use are local responsibilities.

Commissioners may wish to check that organisations have adopted these PGDs as they are a key facilitator for changes in contraception and sexual health services. They may wish to note this as an activity to be added and then regularly monitored at Quality meetings for providers. This will help deliver improved and consistent standards of practice and provide a safer, more accessible and more effective service to users. It will also reduce the duplication of effort required for the development of PGDs in each organisation thus improve efficiency.

The expert panel will remain as a virtual network in order to ensure that the PGDs are updated in a timely manner to reflect any necessary changes e.g. national guidance and for formal review of the PGDs about six months before they are due to expire. We would encourage you to inform the London Sexual Health Programme and your commissioners that you have adopted the PGDs for your services. This will help map and record the effectiveness of the project in achieving the aim to support delivery of consistent standards of care in sexual health across London and will help us maintain a database of contacts for future reference.

STI PGDs

1.Genital Herpes

2. Candidiasis

3. Chlamydia

4. Gonorrhoea

5. BV or TV

6. Genital Warts

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