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Standards/Clinical Governance

NICE PGDs – Template & Baseline assessment tool

1 Oct, 13 | by shellraine, e-Media Editor

Two implementation tools have now been published to support the patient group directions NICE good practice guidance. These are available from the NICE website at the links below:

GPG 2 Patient group directions: baseline assessment tool

GPG 2 Patient group directions: template

Nominations open for the UK Sexual Health Awards 2014

30 Sep, 13 | by shellraine, e-Media Editor

The UK Sexual Health Awards recognise outstanding work in and around sexual health. If you know of any incredible people, projects, services, campaigns, storyline or article – we want to hear about them.

Whether you’re nominating yourself, the organisation you work for, someone you work with, or something that has been done by someone else; if you think it deserves to be recognised and celebrated – make a nomination now!

There are seven categories open for nomination:

  • Sexual health professional of the year
  • Young person of the year
  • Adult sexual health service/project of the year
  • Young people’s sexual health service/project of the year
  • The Pamela Sheridan sex and relationships education award – recognising good practice in education in schools
  • Sexual health media campaign/storyline of the year
  • Rosemary Goodchild Award for excellence in sexual health journalism.

All shortlisted finalists get a free ticket to the glittering awards dinner and ceremony on Friday 14 March 2014 at 8 Northumberland Avenue – a stunning venue in the centre of London, Trafalgar Square.

Visit the Awards website to find out more or contact awards@brook.org.uk

ESC – 13thCongress and call for applications for project funding

16 Sep, 13 | by shellraine, e-Media Editor

Mark your calendar:

28 till 31 May 2014
Lisbon, Portugal

First announcement

Check out the first announcement including:

  • programme overview: 8 workshops, 21 congress sessions, 2 debates…
  • abstract submission instructions (deadline 1 December 2013)
  • registration form

Register now

Please find here an overview of the registration fees.
You can now register through the online registration form

General information / Programme overviewCall for abstracts (deadline = 1st December 2013)/ Registration

ESC newsletter

Call for project or course applications

The ESC provides funding to support a project within Europe

The available budget for applications received between 1 August and 31 December 2013 is 30,000 euro. Applications should meet the following minimal conditions:

  • The applicant must be a paid-up ESC member
  • The grant may be used to support an individual, group, institute or organisation with a project related to the aims of the ESC.
  • Examples of projects include: research, audit, review, needs assessment

Deadline for the application period:  31 December 2013

Application Form

 

 

NICE Good Practice Guidance: Patient Group Directions

2 Aug, 13 | by shellraine, e-Media Editor

The Good Practice Guidance for Patient Group Directions has been published today. Better late than never!

This guidance provides good practice recommendations for individual people and organisations involved with PGDs, with the aim of ensuring patients receive safe and appropriate care and timely access to medicines, in line with legislation.

The preferred way for patients to receive the medicines they need is for a prescriber to provide care for an individual patient on a one-to-one basis. Historically, a doctor (or dentist) would prescribe a medicine(s) for an individual patient. A pharmacist (or dispensing doctor) would then dispense the medicine against the prescription and supply the medicine(s) to the patient.

This traditional ‘medical model’ changed in the years after publication of the final Crown report Review of prescribing, supply and administration of medicines in 1999. Legal frameworks were developed that have allowed services to be redesigned and health professionals to work more flexibly for the benefit of patients. As a result of these changes, there are now several legal options for supplying and/or administering medicines, including Patient Group Directions (PGDs).

PGDs provide a legal framework that allows some registered health professionals to supply and/or administer a specified medicine(s) to a pre defined group of patients, without them having to see a doctor (or dentist). However, supplying and/or administering medicines under PGDs should be reserved for situations in which this offers an advantage for patient care, without compromising patient safety.

Legislation establishing PGDs was introduced in 2000 and the Health Service Circular (HSC 2000/026) provided additional guidance. The current legislation for PGDs is included in The Human Medicines Regulations 2012.

This guidance is written in the context of the NHS in England, including independent organisations or contractors who are commissioned to provide NHS services. It may also be applicable to individual people and organisations delivering non-NHS healthcare services, and to some of the devolved administrations.

The guidance can be found here.

 

 

Faculty 20th Anniversary Celebration & McGonagall’s Ode!

19 Jul, 13 | by shellraine, e-Media Editor

At the event to celebrate the Faculty’s 20th anniversary, those gathered were regaled, by the invited after-dinner speaker Professor James Drife, with the following ode – available as a podcast for best effect:

The Editor felt the Journal’s readers might like to share the experience, although nothing could compare with seeing the performance ‘live’.

When not engaged in composing and reciting poetry, Professor Drife’s day job is Professor of Obstetrics and Gynaecology at the University of Leeds, Leeds, UK.

JD

McGonagall’s ode to the Faculty of Sexual and Reproductive Health

 

O what a very exciting place this is to be,

On Thursday the sixth of June, in the year 2-0-1-3

The Royal College of Obstetricians and Gynaecologists’ Committee Room One,

Where over the years many mighty medicopolitical deeds have been done.

 

O what beautiful portraits there are on the walls,

Showing how the president’s face lights up when the portrait painter calls!

If only the Faculty also had presidential portraits, I think they would look very fine,

And when viewed as a group would not be so overwhelmingly masculine.

 

The rest of the RCOG is fully occupied with a course right now,

So if you want to run a busy labour ward, there are experts here to tell you how:

But if you prefer your labour ward to be under-occupied and have rooms to spare,

You should follow the guidance of the Faculty of Sexual and Reproductive Healthcare.

 

For the Faculty tells people what to do with their cap, pill, condom, LARC or coil

If they wish to avoid pregnancy and parenthood and all that worry and toil,

And instead continue their careers, travel to far-off lands,

And feel free to buy new furniture, use moisturiser and eat from non-stick frying pans.

 

Tonight we are here to celebrate the Faculty’s 20th anniversary,

Which is why we have come from many distant places to London, NW1 4RG.

I myself have travelled from Dundee, by the new railway bridge over the silver Tay,

Which unlike the old one, has stayed up and has not been swept away.

 

But Professor Johannes Bitzer has had an even longer journey than mine –

All the way from Basel, Switzerland, with its historic bridge over the silvery Rhine,

A bridge that, I believe, has a chapel halfway across so you can offer up a prayer –

A feature that our new railway bridge could have done with, but it isnae there.

 

Tonight we also have a Liverpool delegation, which is small but select:

Meera Kishen, an ex-president, and John Ashton and David Richmond, presidents-elect.

The first RCOG president was from Liverpool, and still today if you’re feeling presidential,

Residence in Merseyside evidently remains desirable if not essential.

 

But there are exceptions to every rule, are there not?

President Chris Wilkinson is a Londoner and President Tony Falconer is a Scot,

And the Faculty has had presidents from Bournemouth and Southwark and all over the place,

So clearly my comment about Liverpool is not evidence-based.
For the Faculty is an international organisation, when all is said and done,

With a membership that now stands at 16,271

(Stretching alphabetically from Australia to Zimbabwe, which is many a mile)

And with Honorary Fellows in many exotic places including, as of today, Carlisle.

 

And also in the House of Lords, one of London’s most exclusive addresses,

For our roll-call of Honorary Fellows includes two distinguished baronesses.

Long may the House of Lords continue to play its part in the great political game:

May all the plans for reform be limited to giving it a gender-neutral name.

 

O how grateful we all are for that historic day, Friday the 26th March 1993,

The date of the founding, twenty years ago, of the FFPRHC!

In that same week, there had already been another advance in science and scholarship,

With the launch, on Monday the 22nd March, of the Intel Pentium microchip.

 

So today, both the Faculty and the Intel Pentium microprocessor are 20 years old –

A characteristic they share with three members of One Direction, or so I am told.

How marvellous to share a birthday with a successful microchip and famous boy band,

Neither of which a man of my age is able to understand.

 

But what I do know is that the Faculty is a major force for good in sexual health,

And that its members, fellows and friends represented here are its real wealth.

Aye, of movers and shakers, the honorary Fellows’ list is a veritable encyclopaedia

Which now includes Dr Mike Smith, known as the Big Daddy of doctors in the media.

 

And one other new fellow, who has never joined Mike in front of the microphones

Because other men have already done a show with the title, “Alias Smith and Jones”.

Corin Jones has been with the Faculty, man and boy, since it was called NAFPAD,

And is now retiring, which makes everyone, except Corin, extremely sad.

 

For Corin is the person who for this Faculty, and for over 20 years, has done the most,

And who, as this poem draws towards its end, deserves a toast!

So, to drink the health of Corin and the Faculty, let us rise, one and all,

With a big thank-you from everyone here, including your humble poetic servant, William McGonagall.

 

Jim Drife, with acknowledgments to the Great Bard of Dundee.

 

Fall in abortion rate and other news

15 Jul, 13 | by shellraine, e-Media Editor

Fall in abortion rates continues

Abortions carried out on women living in England and Wales fell 2.5% to 185,122 last year, Department of Health figures show.

For women aged 15-44, the abortion rate was down 5.4% to 16.5 per 1,000 women – the lowest since 1997.
From information included in abortion forms in 2012, almost half were medically-induced using drugs as opposed to surgery – similar to 2011.
Among under-18s, the abortion rate continued to fall last year.
The number of teenagers having abortions has been on a downward trend for the past five years. Between 2011 and 2012, the under-18 abortion rate fell again from 15 to 12.8 per 1,000.
The Department of Health report on the 2012 statistics said that 91% of abortions were carried out before the 13th week of pregnancy.
It also noted that fewer abortions were carried out on women from other countries, such as Ireland, than in any year since 1969.
Last year, non-residents accounted for 5,850 abortions.

The British Pregnancy Advisory Service (BPAS) said the drop in the number of teenagers experiencing an unwanted pregnancy could reflect improvements in access to contraception for young people.

In older age groups the fall in abortions could indicate that women are better able to avoid unplanned pregnancy in the first place, it said.

DH publishes “Integrated Sexual Health Services : National Service Specification”

This national service specification is provided to help local authorities to commission effective,high-quality, integrated sexual health care . It covers the rationale for commissioning effective and easy to access services and the objectives of service provision, key outcomes to consider, a description of what should be offered at various levels of service, professional and other quality standards covering sexual health, and the need to work in partnership with other services such as termination of pregnancy, general practice, and mental health services.

National curriculum review

From February to April a public consultation on the government’s proposal for the reform of the national curriculum in England was launched. The DfE has published the consultation report and government response. Having considered the responses to the consultation the government has published updated versions of the national curriculum framework and is now seeking feedback on this – deadline 8th August.

Responding to the publication Jules Hillier, Brook’s Deputy Chief Executive, said:

“Brook welcomes the inclusion of compulsory sex and relationships education in the National Curriculum, which means that secondary schools must provide young people with the education we know they very much want and need. It’s now up to schools to put this policy into action by ensuring that all children and young people are given high-quality SRE that puts young people at its heart. Getting this right will contribute to young people’s wider health and wellbeing and help them prepare for safe healthy, happy relationships. We look forward to supporting schools to do this.”

 PRAC recommendation on Diane 35 and generics

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has concluded that the benefits of Diane 35 (cyproterone acetate 2 mg / ethinylestradiol 35 micrograms) and its generics outweigh the risks in a specific patient group, provided that several measures are taken to minimise the risk of thromboembolism, including new contraindications and warnings.

The Committee adopted the recommendation following a thorough review in which it sought expert advice and considered feedback from healthcare professionals and users of these medicines.

 

July Journal published as Impact Factor soars to 2.1!

20 Jun, 13 | by shellraine, e-Media Editor

The July edition of the Journal is now available online and includes:

Venous thromboembolism and COCs: an ongoing saga

This ongoing controversy recently resulted in the decision of the French authorities to withdraw the combined oral contraceptive (COC) containing ethinylestradiol (EE) and cyproterone acetate (i.e. Diane 35®) from the market. This consensus statement from 26 international experts in contraception concludes that “Both epidemiological data and clinical trials must be taken into account when best practice is defined. Regulatory restrictions of previously registered methods should only be made after careful assessment of all the available evidence”. See page 156

Serum CA125 for ovarian cancer screening

This timely commentary raises questions about the widespread use of screening women with non-specific symptoms by measuring serum CA125 levels, following the publication of the NICE guideline on ovarian cancer in 2012. The authors acknowledge that there are barriers that prevent women with symptoms associated with ovarian cancer from presenting to their general practitioner. However, the authors also point out that this will lead to increased use of CA125 in general practice and raise concerns about how women with raised CA125 in the absence of evidence of any disease should be managed. See page 160

Ovarian cancer symptom awareness and help-seeking behaviour

Ovarian cancer symptom awareness is low in the UK, and varies widely between symptoms. In this study, Low et al. identify variables that may be implicated in a longer time to help-seeking for possible ovarian cancer symptoms, and highlights the need for more in-depth research into the factors related to time to help-seeking in real-world situations. See page 163

Fertility preservation decisions faced by women with breast cancer

This article presents a contemporary summary of fertility preservation techniques available to women of reproductive age with breast cancer. It offers unique insights into the difficult treatment decisions coupled with the difficult fertility preservation treatment decisions that these women face. The article highlights a number of themes that influence the decision-making process for these women. Egg and embryo banking appear to be the fertility preservation treatment of choice. Finally, this work may assist health care commissioners when deciding funding priorities within a health economy such as the NHS in the UK. See page 172

Correlates of unprotected sex in drug-injecting women

This study demonstrates that despite the high risk for HIV acquisition or transmission and unintended pregnancy, condom use among women who inject illicit drugs or who have sexual partners who inject drugs in St Petersburg in Russia is low. Programmes to investigate and improve contraceptive use, including condoms, among this vulnerable group of women are needed and might benefit from addressing alcohol misuse. See page 179

Contraception in a university environment

This is a very simple real-life observational study of a cohort of young, nulliparous women in a university-based general practice choosing and continuing with long-acting reversible contraceptive methods (LARCs) as their first line method of contraception. This article urges the health professional reader to consider offering this ‘fit and forget’ method of contraceptive to our younger population as a matter of routine. See page 186

Impact of UKMEC on CHC prescribing

Briggs et al. have assessed the effect of the UKMEC on prescribing of combined hormonal contraceptives (CHCs). Sadly, although there has been a small decrease in the proportion of higher-risk women being prescribed CHCs, their results suggest that in 2010 7.3% of CHC users had UKMEC Category 3 or 4 risk factors, particularly BMI ≥35 kg/m2. The authors point out that it is likely many of these women were being placed at an unnecessarily high risk of cardiovascular events, given the availability of lower-risk alternatives. See page 190

Financial cost to patients of a suspected ectopic pregnancy

In this article, Unger and colleagues in Edinburgh report on their assessment of an area of patient experience that is not often considered when assessing medical interventions. The financial impact on patients’ lives of the need to seek medical attention can be considerable and may become more significant as economic hardship increases. This article describes a well-conducted questionnaire study on the costs that patients themselves incurred in attending their general practitioners and a hospital clinic with a suspected ectopic pregnancy. The authors argue that such costs need to be factored into decisions regarding the cost-effectiveness of medical procedures. See page 197

Emergency contraception algorithm based on risk assessment

Introduction of a standardised protocol for the provision of emergency contraception (EC) has significantly increased the proportion of women offered an intrauterine device (IUD) as postcoital contraception, particularly in women at high risk of conception. Introduction of ulipristal acetate as an alternative method of EC has resulted in a reduction in the uptake of the emergency IUD. McKay and Gilbert state that this is cause for concern, and further investigation into the reasons behind this decrease in IUD uptake is needed. See page 201

No need for water torture

Cameron and colleagues set out to answer a simple question, namely does a full bladder assist insertion of intrauterine contraception? In the world of assisted conception a full bladder had been shown to aid intrauterine catheter insertion for embryo transfer, but could this knowledge be transferred usefully to the world of contraception? This simple question was answered in a simple and elegant way with a properly constructed and conducted randomised trial, which showed that we needn’t ask our clients requesting IUD/IUS insertion to arrive bursting – a fact for which both they and clinic staff will be duly grateful. See page 207

New monophasic natural estradiol COC

Lee Shulman reviews a new monophasic natural estradiol COC, Zoely®. This COC benefits from the progestogen nomegestrol acetate (NOMAC), which appears to result in good cycle control, with a 24/4 regimen. Since it is monophasic, it also has potential for extended cycle use. The great hope is that natural estradiol COCs will have a lower risk of venous thromboembolism (VTE) than EE-containing pills, but it should be stressed that there is currently no actual evidence for this. Studies are ongoing, but at present these COCs should be treated just like any other from the point of view of VTE. See page 211

Brook/FPA UK Sexual Health Awards 2013

The Journal’s Consumer Correspondent writes about the recently awarded Brook/FPA UK Sexual Health Awards, and opines that awards of this type are a good thing for the SRH profession generally and so rightly should be regarded as a highlight of the sexual health year. See page 219

Plus

An obituary for Dr Alison Bigrigg by Dr Audrey Brown; an organisational factfile on Tommys; a conference report from the FSRH Annual Scientific Meeting at University of Warwick;

And last, but by no means least, the Journal Impact Factor has risen, once again, to 2.1. Many congratulations to Anne Szarewski and her team.

 

New injectable – Sayana Press and Dianette VTE update

17 Jun, 13 | by shellraine, e-Media Editor

Sayana Press®

is a progestogen-only injectable contraceptive licensed for subcutaneous use. It contains 104mg of medroxyprogesterone acetate (MPA) in 0.65ml suspension and is bioequivalent to IM depot medroxyprogesterone acetate. It is administered at intervals of 13 weeks +/- 7 days via a new delivery system (Unijet) – a single dose pre-filled injector.

Sayana

Although ideal for self-administration it is not currently licensed for use in this way.  The April issue of the Journal included a commentary on SC MPA by Sharon Cameron from Edinburgh.

Further information for professionals including a step-by-step administration guide will be available via MedIsis website.

Dianette® and cyproterone acetate products: strengthening of warnings, new contraindications, and updated indication

In agreement with the MHRA and European Medicines Agency (EMA) Bayer has written to health professionals about Dianette®, co-cyprindiol and cyproterone acetate products. This follows the outcome of a review of the known risk of thromboembolic events by the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC). There are no new data, but there has been a “scare” in France which led to this and other so-called third generation products being removed from the market leaving very limited options for women.

The PRAC recommendations include:

  • Dianette® and other medicines containing cyproterone acetate 2mg/ethinylestradiol 35 mcg are indicated for the treatment of moderate to severe acne related to androgen-sensitivity (with or without seborrhea) and/or hirsutism, in women of reproductive age.
  • For the treatment of acne, Dianette® and other cyproterone acetate 2mg/ethinylestradiol 35 mcg products should only be used after topical therapy or systemic antibiotic treatment have failed.
  • Since Dianette® and all other cyproterone acetate 2mg/ethinylestradiol 35 mcg products are also a hormonal contraceptive, they should not be used in combination with other hormonal contraceptives.
  • To increase awareness of the risk and risk factors of thromboembolism in relation to the use of Dianette® and other cyproterone acetate 2mg/ethinylestradiol 35 mcg products (e.g. increasing age, smoking, immobility), the warnings and precautions regarding this risk have been strengthened.

 

 

Help WHO revise its guidelines!

15 Apr, 13 | by shellraine, e-Media Editor

The WHO are currently preparing updates to its Medical Eligibility Criteria for Contraceptive Use and Selected Practice Recommendations for Contraceptive Use, which will be finalized in 2014, and are soliciting feedback from various stakeholders in the field of family planning to inform this process. The goal is to ensure these guidelines remain relevant to family planning policies, programmes and service delivery. To that end, they have created a survey to help prioritize topics to review and to determine which new information to add to the guidelines. In addition they welcome other suggestions on how to improve the guidelines.

If you are familiar with the Medical Eligibility Criteria for Contraceptive Use or the Selected Practice Recommendations for Contraceptive Use fill out the survey and give your suggestions for the next edition.

28 Mar, 13 | by shellraine, e-Media Editor

New RCN publication:

Genital examination in women – A resource for skills development and assessment.

The purpose of the document is to provide standards and sample assessment tools for training in genital examination in women for nurses working in sexual and reproductive health settings, and related health and social care settings. It replaces the earlier Vaginal and Genital Examination Guidance for nurses and midwives (2006) and Competencies for nurses undertaking bimanual genital examinations (2011) and acknowledges the input of members of the FSRH Associated Members Working Group and BASHH.

Reminder to register as stakeholder for NICE Patient group directions Good Practice Guidance

Management of PGDs will change from the 1st April when commissioning of services changes. All those involved in development or use of PGDs can contribute at the  consultation stage by registering as a stakeholder now. Individuals can contribute as service providers.

To register your organisation as a stakeholder send registration details (name of contact, name of organisation, email address) to pgd@nice.org.uk using the subject heading Patient group directions GPG stakeholder registration 2012/13

PGD authorisation in new organisational structures – DH update

The Medicines and Healthcare products Regulatory Agency (MHRA) and Department of Health are amending medicines legislation to:

(i) enable Clinical Commissioning Groups, Local Authorities and the NHS Commissioning Board to authorise PGDs from April 2013; and,

(ii) to ensure that existing PGDs with an expiry date after 31 March 2013 will continue to be legal until the PGD either expires or is replaced.

These changes are consequential to the Health and Social Care Act 2012, and will enable the continued use of PGDs in new health system organisational structures.

Transitional arrangements

The legislation will also incorporate transitional arrangements to ensure the continued availability of PGDs during organisational change, and to ensure that staff and organisations are not acting outside the law. These arrangements will allow PGDs to remain legal after the original authorising body (e.g. a PCT) has been abolished, and until expiry or authorisation by the new body responsible for the service in question. Responsibility for PGDs will transfer to these new bodies, and organisations ‘inheriting’ PGDs will need to put in place clear arrangements and a timetable for review and adoption/authorisation of all existing PGDs. Further advice is available in the FAQs section of this website. See links below.

The National Prescribing Centre (NPC) (now the Medicines and Prescribing Centre (MPC) at NICE) has published a practical guide and framework of competencies for organisations and professionals developing and using PGDs. See link below.

The MPC are reviewing this document, including to take account of changes to legislation and organisational structures, with the aim of re-publishing by June  2013. In advance of this updated edition, organisations delivering services under PGDs can still use the existing document to help guide them through the legal framework governing the development and authorisation of PGDs, and to provide practical guidance on their use. As summarised by Angela Bussey, Principal Pharmacist Medicines Information Project, Guy’s and St Thomas’ NHS Foundation Trust.

more from: http://www.nelm.nhs.uk/en/Communities/NeLM/PGDs/News/PGD-authorisation-in-new-organisational-structures–DH-update-/

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