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Drugs – What’s in a name?

6 Dec, 12 | by shellraine, e-Media Editor

Branded, generics or branded generics? Do you know the difference?

When a branded, or proprietary, drug comes ‘off patent’ it is common for other companies to apply for marketing authorisation and we are, increasingly, seeing this in sexual health. This can be for generic versions or for branded generics. Branded generics are simply generic equivalent drugs with a brand name given by the particular company. When a pharmacist dispenses a proprietary drug or branded generic they are obliged to dispense the named product, if a pure generic is prescribed they can give any product containing the generic compound/s but this is reimbursed at the current generic rate.

To give an example in contraception Microgynon 30 & Ovranette are proprietary brands and Levest & Rigevidon are branded generic equivalents.

MeReC bulletin summarises:

  • Generic medicines are, overall, much less expensive to the NHS. Their appropriate use instead of branded medicines delivers considerable cost savings. In England about 5% of medicines are still prescribed by their brand name when generic equivalents are available.
  • List prices for some ‘branded generics’ may be lower than the reimbursement price for equivalent generics. However, any cost savings achieved by their use may be unsustainable by the manufacturer and may not necessarily be cheaper, or in the best interests of the NHS overall.

This may be because many companies marketing branded generics negotiate a fixed price for a fixed period for their products with pharmacies or clinics which are lower than, even, generic alternatives – however generic drug prices are subject to fluctuation due to market forces and may fall over time meaning this would no longer be the case.

The MeReC bulletin also signposts the UK Medicines Information (UKMi) Q & A document “Which medicines are not suitable for generic prescribing in primary care?” This lists medicines that may be considered suitable to prescribe by specific manufacturer’s product (branded or generic). These include:

multiple ingredient products
– ensuring adherence to long-term medications, where differences in appearance between manufacturer’s products might cause confusion and anxiety

In contraception, over the years, we have probably not noticed when this has happened and the first of the reasons above, as well as the fact that there were not many generic versions available, may explain this. The second may be more pertinent in the future.

There are a number of reasons why these issues are currently topical in sexual health:

  • cost saving – not only perceived savings on generics vs brands but increased bulk/group purchasing to afford greater savings within Trusts
  • more companies are making and marketing branded generics than in the past
  • more medicines used in sexual health are due to come off patent now or in the next year including: sildenafil, many HIV drugs, desogestrel and mifepristone
  • increased use of paperless IT systems with built-in drug data bases, as in general practice, where generic equivalents are often highlighted
  • different ordering capabilities of independent pharmacies vs large national companies/chains

There are potentially more likely to be problems with contraceptive pills prescribed in general practice than in clinics as clinics generally see women at each visit and can explain any differences there may be in dispensed products. A woman taking an FP10 to a pharmacy (if it is prescribed generically) may be given a different product from previously without the prescriber being aware that this could occur. And this may happen even if she goes to the same pharmacy as last time. Clinicians will be aware of the issues that arise if women are given different pills and the anxiety this may cause followed by increased clinician time required for extra appointments to handle any problems. This is always assuming the woman doesn’t just stop her pills if she is unable to access help in a timely fashion. Food for thought.

 

ella-One® black triangle removed

The MHRA has removed the black triangle from ella-One®. The black triangle will be removed from all company materials over the next few months and EC providers may need to update some documentation.

European Consortium for Emergency contraception launched at ESC in Athens

3 Aug, 12 | by shellraine, e-Media Editor

The European Consortium for Emergency contraception (ECEC) was launched in Athens on June 21st at the 12th Congress of the European Society for Contraception and Reproductive Health.

Why a European Consortium on EC, now?

  • Access to emergency contraception (EC) is unequal across the region.
  • Absence of a harmonised evidence-based approach to EC recommendations.
  • Current changes in the EC landscape are likely to lead to further inequalities in access to reliable EC options.
  • The International Consortium for Emergency Contraception (ICEC) works to expand access to EC worldwide, but focuses on the developing world.
  • ICEC and partners identified a need to develop a regional platform to serve as an authoritative source of information, and a voice for more equitable access to EC in Europe.

ECEC mission:

To expand knowledge about and access to EC in European countries, and to promote the standardisation of EC services delivery in the European context, to ensure equitable access within the region. (not only with the 27 EU countries, but with all countries considered Europe by the EU and the WHO.)

ECEC objectives:

KNOWLEDGE – Generate knowledge and serve as an information-sharing platform.
RESEARCH – Promote high quality research on EC issues.
ADVOCACY – Disseminate research findings and promote use of evidence-based information for policy and program development.
QUALITY OF CARE – Reduce access inequalities by promoting the standardization of quality of care of EC services across the region.
IEC – Develop and disseminate information, education and training materials.

How to become a member?

Individual membership – Email info@ec-ec.org and join or via http://knowledge-gateway.org/ICEC/Global/ecec

Institutional membership (terms under development).

Other ESC News

The Congress in Athens was well attended (1400 delegates) despite the reduction in drug company support, most notably for UK clinicians.

At the General Assembly the venue for the 2016 Congress was voted for and won by Basle in Switzerland, which is also the base of the current president – Johannes Bitzer.

  •  In case you hadn’t heard there is an extra Congress next year – the first Global Congress – in Copenhagen. An outline programme, information and calls for papers are available from the website: www.escrh.eu. The abstract submission deadline is 15 December 2012. Why not send something in? You may win an award: best poster, best free communication and for the under 35s, best Young Scientist.
  • The next biennial Congress is in 2014 and will be in Lisbon.

At the Board meeting Professor Kristina Gemzell-Danielsson, from the Karolinska Institute in Sweden, was elected Vice President.

 

 

 

Abortion & STI data published

7 Jun, 12 | by shellraine, e-Media Editor

WHO updated policy on safe abortion

The WHO has announced the iminent publication of the second edition of ‘Safe abortion: technical and policy guidance for health systems’

http://www.who.int/reproductivehealth/publications/unsafe_abortion/9789241548434/en/

DH releases abortion statistics, England & Wales: 2011

The main findings of the newly released abortion statistics are:
•    The total number of abortions was 189,931, 0.2% more than in 2010 (189,574) and 7.7% more than in 2001 (176,364).
•    The age-standardised abortion rate was 17.5 per 1,000 resident women aged 15-44, the same as in 2010, but 2.3% higher than in 2001 (17.1) and more than double the rate of 8.0 recorded in 1970.
•    The abortion rate was highest at 33 per 1,000 for women aged 20, the same as in 2010 and in 2001.
•    The under-16 abortion rate was 3.4 per 1,000 women and the under-18 rate was 15.0 per 1,000 women, both lower than in 2010 (3.9 and 16.5 per 1,000 women respectively) and in the year 2001 (3.7 and 18.0 per 1,000 women respectively).
•    96% of abortions were funded by the NHS.  Over half (61%) took place in the independent sector under NHS contract, up from 59% in 2010 and 2% in 1981.
•    91% of abortions were carried out at under 13 weeks gestation.  78% were at under 10 weeks compared to 77% in 2010 and 58% in 2001.
•    Medical abortions accounted for 47% of the total, up from 43% in 2010 and 13% in 2001.
•    2,307 abortions (1%) were carried out under ground E (risk that the child would be born handicapped).

Non-residents:
•    In 2011, there were 6,151 abortions for non-residents carried out in hospitals and clinics in England and Wales (6,535 in 2010).  The 2011 total is the lowest in any year since 1969.

FPA reacts to the release of abortion statistics

Julia Bentley, Chief Executive, welcomed the decrease in abortions for under 16s and under 18s alongside a very small increase in the total number overall while highlighting the worrying trend in restrictions to contraceptive service provision.

New data show STI diagnoses on the rise in England

Figures released by the Health Protection Agency (HPA) show new sexually transmitted infection (STI) diagnoses rose by 2% in England in 2011, with nearly 427,000 new cases, reversing the small decline observed the previous year. Young heterosexual adults (15-24 years) and men who have sex with men (MSM) remain the groups at highest risk. More

Joint statement from FPA and Brook on STI data 

In a joint statement the sexual health charities said: “This is a worrying reverse trend. It demonstrates exactly why safer sex messages and campaigns that young people and gay men will listen to and take action on, are absolutely necessary. Testing and treatment services are vital, but alone they are not enough to change people’s behaviour. The impact of the government’s disinvestment in campaigning around safer sex and sexual health reflects in today’s statistics. Yet again we see more data illustrating why there is an urgent need for statutory sex and relationships education in schools alongside sustained investment in sexual health services.”

WHO: Urgent action needed to prevent the spread of untreatable gonorrhoea

Millions of people with gonorrhoea may be at risk of running out of treatment options unless urgent action is taken, according WHO. Already several countries, including Australia, France, Japan, Norway, Sweden and the United Kingdom are reporting cases of resistance to cephalosporin antibiotics – the last treatment option against gonorrhoea. Every year an estimated 106 million people are infected with gonorrhea, which is transmitted sexually. More:

Policymakers Recommit to Unfinished Agenda of Landmark Cairo Population Conference

In Istanbul, on 25 May lawmakers from 110 countries reaffirmed their support to the principles and goals of the 1994 Cairo International Conference on Population and Development (ICPD), emphasizing their continued centrality to efforts to reduce poverty and safeguard people’s health and rights, including sexual and reproductive health and reproductive rights. Press release

 

SRH Reports from around the globe

25 May, 12 | by shellraine, e-Media Editor

International Campaign for Women’s Right to Safe Abortion

The ICMA have launched a new international campaign for women’s right to safe abortion. Individuals and organisations are invited to join the campaign in advance of 28 May, the International Day of Action for Women’s Health. To read more and to register support go to https://www.surveymonkey.com/s/CHH62F5

UNFPA announces ‘Maternal Deaths Halved in 20 Years’.

The number of women dying of pregnancy and childbirth related complications has almost halved in 20 years, according to new estimates released by the World Health Organization (WHO), United Nations Children’s Fund (UNICEF), United Nations Population Fund (UNFPA) and the World Bank.

US regulators vote for approval of PrEP by large majority.

The US Food and Drug Administration (FDA) have taken a decisive step towards approving the use of the combination pill Truvada (tenofovir/FTC) as a prevention method for HIV-negative people. Read more at NAMaidsmap. GlobalData.com reported on 11th May – In a controversial decision on May 10, the FDA antiviral drugs advisory committee backed Gilead Sciences’ drug Truvada to prevent the transmission of HIV. The committee voted in favour of prophylactic Truvada in three populations: HIV-uninfected men who have sex with men (19-3), in HIV-uninfected partners in relationships with infected partners (19-2), and for individuals at risk of acquiring HIV through sexual activity (12-8).  Although awareness of HIV and AIDs has significantly increased throughout recent decades, the disease remains a global epidemic requiring better preventative strategies. Yet the possibility that on June 15 the FDA will approve Truvada for pre-exposure prophylaxis (PrEP) has provoked strong and divided opinions from infectious disease experts and activists. Read more at globaldata.com

Victories for Center for Reproductive Rights

Victory for Honduran Women

On May 17, 2012, the Center for Reproductive Rights held a demonstration on the steps of the Honduran Congress. Their mission: to stop the government from passing a bill that would have imprisoned women for using emergency contraception. Alejandra Cárdenas, Legal Adviser for Latin America and the Caribbean, had planned to personally hand-deliver 730,000 petitions to the Congress signed by activists in more than 80 countries in protest. In a surprise move, Juan Orlando Hernández, president of the Congress, declined to take the petitions—but not because he didn’t hear the massive outcry. In fact, Hernández said he no longer planned to bring the bill up for debate—and even proclaimed support for women’s self-determination. Read more:

Two Groundbreaking Victories in Oklahoma:

Medication Abortion Protected

Judge Donald Worthington permanently blocked a state ban on medical abortion when he ruled that the law was “so completely at odds” with standard medical practice that it “can serve no purpose other than to prevent women from obtaining abortions and to punish and discriminate against those women who do. Read more:

and Oklahoma Personhood defeated

With a unanimous decision by the Oklahoma Supreme Court, the Center for Reproductive Rights has won its legal challenge to strike down a ballot initiative that would have given every fertilized egg the full legal rights of a person. It is not acceptable, they ruled, to propose amendments to the state constitution that are ‘repugnant to the Constitution of the United States.’” If passed, the amendment not only would have outlawed abortion in all cases—including in cases of rape or incest, fetal anomalies, or risk to a woman’s life—but also would have banned many forms of birth control and seriously threatened fertility treatments such as IVF. Read more:

Distress of child war and sex abuse victims halved by new trauma intervention

A new psychological intervention has been shown to more than halve the trauma experienced by child victims of war, rape and sexual abuse. Researchers at Queen’s University Belfast pioneered the intervention in conjunction with the international NGO, World Vision as part of a wider programme to treat psychological distress in child victims of war and sexual violence in the Democratic Republic of Congo (DRC). Read more:

Faculty Initiatives & Fitness to Practice

24 May, 12 | by shellraine, e-Media Editor

Crucial Issues for Health Joint Strategic Needs Assessments and Local Health & Wellbeing Strategies

Joint Guidance has been published by FSRH, BASHH, fpa, Brook, BHIVA, MedFASH, NAT, THT & NHIVNA to guide and assist Local Authorities who are preparing to commission sexual & reproductive health & HIV services when local government takes up its new public health responsibilities in April 2013.  In the coming months every Local Authority will need to:
- complete a Health Joint Strategic Needs Assessment (JSNA)
- establish a Health & Wellbeing Strategy & investment plan
- prepare to commission public health services.

FSRH response to APPG inquiry

The Faculty has published its response to the APPG on SRH inquiry into restriction on access to contraceptive services as outlined in the blog of 20th April.

Workforce Census 2012

Service representatives are directed to the Faculty Workforce Census for 2012. Forms are available online via the FSRH website and need to be completed by 30th June 2012.

GMC Fitness to Practise reforms

From 11 June 2012 the Medical Practitioners Tribunal Service (MPTS) will be the new impartial adjudication service for the medical profession in the UK. The MPTS will hear all fitness to practise cases about doctors and makes decisions on what action is needed to protect patients, if any. The MPTS is part of the GMC, but it is operationally separate from the GMC’s work in investigating complaints about doctors and presenting cases at hearings. Complete guide to the MPTS available from FSRH website.

NHS flouts national guidance on contraception as cuts bite:

25 Apr, 12 | by shellraine, e-Media Editor

new audit reveals shocking truth as 3.2m women face restrictions in access to contraceptives or services

A new audit of the commissioning of contraceptive and abortion services in England has revealed a stark picture of inequality in women’s healthcare, with a third of women of reproductive age unable to choose from the full range of contraceptives or services in their local area.

The audit was carried out by the Advisory Group on Contraception – a coalition of leading experts and advocacy groups interested in sexual and reproductive health – through Freedom of Information requests made to Primary Care Trusts (PCTs). The report of the audit findings, Sex, lives, and commissioning: An audit of the commissioning of contraceptive and abortion services in England demonstrates that:

As many as 3.2 million women of reproductive age (15-44) are living in areas where fully comprehensive contraceptive services, through community and/or primary care services, are not provided

  • Those PCTs restricting access to contraceptives or contraceptive services had a higher abortion rate than the national average
  • Over a quarter (28%) of PCTs responding to the audit did not have a strategy in place or under development to address unintended pregnancy and the need for abortion or repeat abortion

The audit also uncovered evidence of PCTs introducing access restrictions based on cost rather than choice or quality:

  • NHS North Lancashire confirmed one method of contraception was not prescribed “due to lack of funding/training for staff”
  • NHS Brighton and Hove confirmed that its “GP-led health centre will only prescribe Long Acting Reversible Contraceptive (LARC) methods to residents of Brighton and Hove.  Non-residents attending with a filled prescription for LARC will be provided with a fitting”
  • NHS Haringey Teaching said that from the 1 October 2011 “women aged over 25 do not receive contraception pills from the local CaSH [Contraception and Sexual Health] Service; they receive this service from their GP”
  • NHS Barnet stated that “In 2010 the PCT introduced a restriction on over 25’s accessing integrated services for generic contraceptive advice… Only patients within this age group who have complex needs can be seen by an integrated service”

Dr Connie Smith, Consultant in Sexual and Reproductive Healthcare, said:

“Contraception is a very personal issue.  What is right for one woman may not be right for another.  That is why the national NICE guidelines on contraception are built around the importance of choice. 

 “PCTs that are restricting choice are getting worse outcomes.  As a result of flouting national guidance, women are paying a big personal cost and the NHS is bearing a huge financial cost.  Unintended pregnancy costs the NHS more than £755 million every year.  For every £1 spent on contraception the NHS saves £12.50, so restricting access and choice is a complete false economy, harming women and the NHS.  Those PCTs with restrictions in place need to have an urgent rethink.”

Dr Anne Connolly, a GP with a special interest in sexual health, added:

“As a GP I know how important it is to get contraception right.  We must take a personal approach to meeting women’s needs and operating a blanket ban on some services or contraceptives goes completely against this. 

 “It is very concerning that so many PCTs have no strategy in place to address unintended pregnancy and that some are introducing restrictions on contraceptives or services.  The Department of Health should urgently publish a sexual health strategy showing how the needs of women of all ages can be met, alongside clear standards about the quality of service women have a right to expect.”

The AGC has made a series of recommendations for how sexual health and contraceptive services could be more effectively planned, commissioned and delivered.  These include:

  • The Department of Health should publish its planned sexual health policy document without further delay and ensure that it sets out clearly the expectation for commissioners to commission comprehensive, open access services that reflect a life-course approach for people of all ages
  • NICE should prioritise the development of the quality standard on contraceptive services
  • Contraceptive services must be commissioned based on the principles of the NHS Constitution. Commissioners should remove any policies or contracts in place which limit an individual’s access to contraceptive services based on reasons of age or place of residence
  • Commissioners should ensure that up-to-date strategies are in place to reduce unintended pregnancy, and the need for abortion and repeat abortions, and these strategies should focus on addressing the needs of women of all ages

All Party Parliamentary Group launches enquiry into restrictions in access to contraceptive services.

20 Apr, 12 | by shellraine, e-Media Editor

The All-Party Parliamentary Group on Sexual and Reproductive Health in the UK (APPGSRH) has launched an inquiry and call for evidence into restrictions in access to contraceptive services.

Examples have already been seen of commissioners cutting prescribing budgets for contraceptive methods to meet targets for savings, with consequences for choice and public health outcomes. In addition the Public Health Minister, Anne Milton MP, in a response to a parliamentary question tabled on contraceptive services, has recently confirmed that the Department of Health has received “representations from clinicians and voluntary sector organisations on the current commissioning of contraception by primary care trusts (PCTs) and access to certain types of contraception by certain age groups”.

On Monday 6 February, the APPGSRH held a meeting to discuss possible restrictions in access to sexual health services to residents-only and to people under 25 years old.  During the meeting members of the Advisory Group on Contraception (AGC) presented the initial findings from a Freedom of Information audit which had found variations in access to contraceptive services and methods.

The APPGSRH expressed concerns at the findings from the audit, in particular:

  • Evidence of commissioners restricting access to contraceptive services on the basis of age or place of residence
  • The impact that the drive for efficiency savings is having on women’s choice of the full range of contraceptive methods
  • Some methods of contraception only being made available with a GP referral
  • The impact of changes to the commissioning structures on the continuity and quality of contraceptive care

The APPGSRH is launching this inquiry in the belief that its work can contribute to the debate about how high quality contraceptive services can be delivered in the context of the healthcare reforms; and how access to the full range of contraceptive services and methods can be improved for women of all ages.

The inquiry will bring together further evidence and understanding to the current provision of contraceptive services across the country. It will also look at uncovering examples of good practice in relation to the availability of contraceptive services which can be shared amongst new and emerging commissioners of services.  We are therefore encouraging stakeholders – including commissioners, healthcare professionals and service user representatives – to submit written evidence which will help feed into the inquiry’s discussions.

Call for written evidence

The deadline for written evidence is 5pm on Friday 18 May and submissions should be sent to appg@fpa.org.uk. Submissions should be no more than 2,500 words. For more information click here.


 

Review of the year 2011

6 Jan, 12 | by shellraine, e-Media Editor

It has been a busy and eventful year in sexual and reproductive health:

January

saw the launch of the new-look Journal of Family Planning & Reproductive Health Care as it joined the BMJ family. Readers will have noticed many improvements, not least the website and early online publishing.

February

The joint Faculty / e-Learning for Health, e-SRH, was named winner in the e-Government National Award: excellence, Learning & Skills section (now renamed UK Public Sector Digital Awards)

March saw the MDU statement: GPs need suitable training to fit contraceptive implants

April saw the Faculty response to EC being made available through pharmacies in Wales

May saw the publication of the new Missed Pill Recommendations

June

saw Chris Wilkinson become the newly elected President of the Faculty and in
July his appoinment was acknowledged in BMA News


August

saw the publication of the Emergency Contraception Guidelines



September
saw the publication of the amended Drug Interactions with Hormonal Contraception and the launch of this Blog !!

October saw the publication of the Combined Hormonal Contraception Guidelines as the world population broke the 7 billion mark.

November
saw the CEU being awarded NHS Accreditation for its guidelines and the publication of the Service Standards for SRH

December
saw the 23rd World AIDS Day with the theme: Getting to Zero

And so to 2012 – wishing all our readers a Happy New Year

RCOG – Abortion Guidelines & Honorary Fellowships

25 Nov, 11 | by shellraine, e-Media Editor

The Royal College of Obstetricians and Gynaecologists (RCOG) has, this week, published its revised guidelines on the care of women requesting induced abortion. The recommendations cover commissioning and organising services, possible side effects and complications, pre-abortion management, abortion procedures and follow up care.  A summary of new and improved recommendations and link to Q&A’s are in the RCOG press release.

Medical Students for Choice (MSFC) – based in the US, is a non-profit organisation recognising the need to create abortion providers for tomorrow:  www.medicalstudentsforchoice.org. They aim to try and correct the drastically falling numbers of providers in the US and Canada – 57% of current providers are over 50. This along with targeted violence, restrictive legislation and medical schools not addressing the issue means doctors are qualifying with little knowledge of abortion.

RCOG Honorary Fellowship

Toni Belfield

Our friend and colleague, Toni Belfield, has, today, been awarded an RCOG honorary fellowship in recognition of her long service in the field of contraception and sexual health and passionate dedication to providing accessible, evidence-based information for men and women. Included in the citation Professor Janice Rymer noted responses from colleagues who said Toni is “One of the most knowledgeable people in women’s health” and “Her contribution is always very sound”.  Her many friends in the field know, love and respect her as an ardent advocate for service users (never patients or clients!) and as someone who always keeps us on our toes when it comes to accurate use of terminology – we always fit IUDs never coils! Congratulations Toni.

Take Action! Respond to the PSHE Review – Deadline 30th November

The Department for Education is running a Review of PSHE including Sex & Relationships Education with a view to improving its delivery in state funded schools. You can read the review and respond online by following the link. The British Humanist Association has succintly summarised the situation and the fears of many in its statement to accompany its own response.


Surveys & Statistics

21 Oct, 11 | by shellraine, e-Media Editor

SHout Loud

(Sexual Health Out Loud) is a website based on a partnership between Terrence Higgins Trust, FPA, African Health Policy Network, National AIDS Trust, MedFASH and Brook. It aims to provide information about sexual health by geographical area. It is conducting 2 surveys, one for service users and one for service providers with the aim of monitoring changes in service delivery in light of funding difficulties.

Did you see the on-line poll on the front page of the Journal website? It asked for your views on the hot topic of whether to routinely offer local anaesthesia to women undergoing IUD/IUS insertions. Though many people have accessed the page not many took the time to answer the question. This issue has caused much discussion as you may have seen in the last 3 issues since the original letter from Dr Sam Hutt in January. To answer now, please click on the image to the left.

Sexual and Reproductive Health Activity Dataset,

aka SHRAD replaced the KT31 which is/are due to ‘retire’ in 2013. How are you coping with the new way of collecting our activity data? The latest edition of the SHRAD newsletter (no 5) is now available via the Faculty website.

And in the News

The GMC has announced a consultation on 2 future pillars of medical professionalism: CPD and revalidation. More info and access to the consultation on the GMC website.

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