New toolkit by The Medicines and Healthcare products Regulatory Agency (MHRA)
The Medicines and Healthcare products Regulatory Agency (MHRA) today welcomed the launch of a new toolkit to ensure female patients are better informed about the risks of taking valproate medicines during pregnancy.
Valproate (Epilim, Depakote and other generic brands) is a treatment for epilepsy and bipolar disorder and is prescribed to thousands of women. It is associated with a risk of birth defects and developmental disorders in children born to women who take valproate during pregnancy.
MHRA strengthened warnings on the risks of valproate in pregnancy last year, as understanding of the extent of these risks had increased. Up to 4 in 10 babies are at risk of developmental disorders, and approximately 1 in 10 are at risk of birth defects, if valproate is taken during pregnancy. The new toolkit addresses concerns that the risks of valproate are not being adequately explained to female patients.
Developed in consultation with stakeholders including healthcare professional and patient groups, the toolkit includes a credit card sized patient card to be issued by pharmacists, booklets for healthcare professionals and for patients together with a checklist of important questions and discussion points to be kept with the patient’s file. Warnings will appear on the medicine’s packaging later this year.
The MHRA is asking GPs, pharmacists, neurologists, psychiatrists, and other relevant healthcare and mental health professionals to use the toolkit to help facilitate discussion of the risks with their patients.
Sources and more information
New toolkit supports better understanding of the risks of valproate and pregnancy, GOV.UK Press release, 8 February 2016.
Toolkit on the risks of valproate medicines in female patients, GOV.UK Guidance, 8 February 2016.
The Yellow Card is a free smartphone app for reporting suspected side effects (or adverse drug reactions) to the UK’s Yellow Card Scheme. Created in collaboration with the Medicines and Healthcare products Regulatory Agency (MHRA), the UK government medicines watchdog, the Yellow Card Smartphone App is the only health app that allows you to report medicine side effects directly to the Yellow Card Scheme to help the MHRA ensure they are acceptably safe for patients. Users can select specific medicines or vaccines to track and receive news and alerts about them.
Yellow Card Smartphone App Key Features
provide a convenient alternative to using paper Yellow Card forms or the Yellow Card website
the app is free to use for everyone on iOS and Android
is easy to use for reporting side effects directly to the Yellow Card Scheme
enables users to:
create a ‘watch list’ of medications to receive official news and alerts on
view numbers of Yellow Cards received by MHRA for medicines of interest
see immediate response that shows Yellow Card has been accepted
submit updates to Yellow Cards already submitted
view previous Yellow Cards submitted through the app
Mick Foy, Group Manager for MHRA’s Vigilance and Risk Management of medicines division said:
” The contribution of patients, careers and healthcare professionals alike in reporting suspected side effects to the Yellow Card Scheme is vital. The evidence helps MHRA detect safety issues and take the necessary action to keep the public safe.
Moving Yellow Card onto a mobile app is a logical progression in this digital age, allowing us to build on the existing website to improve user engagement. It offers some good functionality to access further safety information, and it will continue to evolve over the course of the WEB-RADR project based on user feedback. “
Life Sciences Minister George Freeman MP commented:
” The Yellow Card Scheme has played a vital role in the safety of medicines for the last 50 years and the launch of this new mobile app brings it into the 21st century.
By making the scheme accessible to researchers, healthcare professionals and millions of patients, it will not only improve the safety of reporting but ultimately better protect people’s health and support research in the NHS. “
More info and videos
Download the free app on iTunes and GooglePlay to easily report drug side effects directly to the Yellow Card Scheme via your cell phone or tablet.
Digital evolution for ground-breaking Yellow Card Scheme, GOV.UK press release, 14 July 2015.
George Freeman talks about the benefits of the new health app from the UK MHRA
In this video published by MHRAgovuk on 14 Jul 2015 , George Freeman talks about the benefits of the UK Medicines and Healthcare products Regulatory Agency new Yellow Card free app.
More info and videos
The new Yellow Card smartphone app supplements an existing one-stop website and is the only app that allows patients, carers and healthcare professionals to report medicine side effects directly to the Yellow Card Scheme to help MHRA ensure they are acceptably safe for patients. Users can select specific medicines or vaccines to track and receive news and alerts about them.
The UK has had its fair share of criticism when it comes to clinical trials delivery. With European counterparts often cited as more reliable, less expensive and quicker to set up, it can be a hard sell to ensure that outdated information is consigned to the past. However, figures released last summer are helping to change perceptions. They show that the performance of commercial contract studies supported by the network is on the up, and the global life-sciences community is starting to take notice.
Medicines and Healthcare products Regulatory Agency (MHRA) figures show a decline in the number of commercial contract clinical studies up to 2011, but more recent figures show that since then, the number of commercial phase II-IV studies has risen from 497 in 2011 to 624 in 2013.
Dr Martin O’Kane is acting head of the clinical trials unit at MHRA. He believes the decline in clinical trials was never as bad in the UK as it was in the rest of Europe and that we are regarded as a proficient nation by commercial companies.
“It is not the case that in the past four to five years there has been a decline in the number of commercial trials in the UK. In fact we have seen numbers rise in recent years,” he says.
“The UK is currently the single largest competent authority in Europe in terms of applications received and is seen as extremely approachable and competent when it comes to delivery.”
Jonathan Sheffield, chief executive officer of the Clinical Research Network, believes the support on offer to the life-sciences industry from the network has had the upmost effect on the way the UK is viewed when it comes to commercial research.
“The network has led the transformation of the clinical research landscape,” he says. “It has made game changing progress for commercial contract research with industry partners telling us that there is a real uplift in the number of commercial studies being awarded to the UK.
“The annual statistics released by the network [last] June showed that last year the network was supporting more than 900 commercial contract studies in the NHS – a 31% increase on the previous year and nearly 10 times the number in 2008-09. This is a phenomenal turnaround in a relatively short period of time and one that shows the commercial world that we are here and ready to deliver.”
The seizures – the biggest recorded to date in the UK – include huge quantities of illegally supplied and potentially harmful slimming pills, erectile dysfunction tablets, anaemia tablets and narcolepsy tablets. Unlicensed foreign medicines and fake condoms were also found and removed.
The seizures are a result of a month-long international crackdown on the illegal internet trade of medical products that yielded £51.6 million worth of items from 115 different countries globally.
The ‘Operation Pangea VIII’ initiative, coordinated through INTERPOL, concluded with a week of international raids between 9 and 16 June that resulted in 156 arrests worldwide.
The operation also targeted websites that were offering falsified, counterfeit and unlicensed medicines and led to their closure or suspension by removal of their domain name or payment facility.
In the UK, MHRA enforcement officers, with assistance from local police, raided known addresses in connection with the illegal internet supply of potentially harmful medicines.
It resulted in the domestic seizure of almost 6.2 million doses of falsified, counterfeit and unlicensed medicines, 15,000 of which were medical devices with a total value of £15.8 million. The UK operation also resulted in 1,380 websites being closed down, 339 of which were domestic sites.
MHRA Head of Enforcement, Alastair Jeffrey, said:
” Operation Pangea is the global response to internet-facilitated medicines and devices crime. As a result of our intelligence-led enforcement operations we have seized £15.8 million worth of counterfeit and unlicensed medicines and 15,000 devices in the UK alone – which is almost twice as much as we recorded last year, and clear evidence that this is a growing concern that has to be taken seriously.
Criminals involved in the illegal supply of medical products through the internet aren’t interested in your health – they are interested in your money and are able to get this by selling you a potentially dangerous product, or by stealing your bank details. To protect your health, visit your GP, get a correct diagnosis and buy medicines from a legitimate high street or registered pharmacy which can trade online. “
A breakdown of the UK seizures highlights the growing trend towards lifestyle medications and products that are unlicensed, falsified or controlled under the Misuse of Drugs Act 1971.
The majority of the products seized in UK originated from India, China, Hong Kong and Singapore.
MHRA has continued to target YouTube accounts and videos as criminals seek to exploit new channels to profit from the illegal sale of medicines – resulting in the removal of more than 320 videos.
Internationally, results show that almost 150,000 packages were inspected by regulators and customs officials, resulting in the seizure of over 20.7 million doses of unlicensed and counterfeit medicines worth approximately £51.6 million.
Alex Lawther, from Border Force’s postal command, added:
” Border Force regularly detects and seizes illegal and restricted products imported through the postal system including fake and unlicensed medicines. Our involvement in this operation with the MHRA demonstrates our commitment to combat this form of smuggling.
Our message to the public is simple – don’t buy anything online unless you are certain it comes from a legitimate source.”
If someone suspects their medicine may be counterfeit, contact the MHRA’s designated 24-hour anti-counterfeiting hotline on 020 3080 6701 or email.
Sources and more information
UK leads the way with £15.8 million seizure in global operation targeting counterfeit and unlicensed medicines and devices, GOV.UK MHRA, 18 June 2015.
UK authorities seize almost £16m of illegal medicines in a month, theguardian.com, 18 June 2015.
Record ‘fake drugs’ haul worth £16m by UK agency, BBC Health News, 18 June 2015.
Report medicine side effect using the Yellow Card Scheme
Are you taking a medicine and suffering from a suspected side effect? Speak to your doctor or pharmacist. Tell us about your side effect. Report it using the Yellow Card Scheme. Help make medicines safer for everyone. Video published on 30 Apr 2013 by MHRAgovuk.
Public call for evidence launched relating to the use of hormonal contraceptives
The Medicines and Healthcare products Regulatory Agency (MHRA) has today launched a public call for evidence relating to the use of oral hormonal pregnancy tests (HPTs, which are no longer prescribed in the UK) and adverse effects relating to pregnancy including possible birth defects.
HPTs such as Primodos were available in the 1960s and 1970s and were widely used to diagnose pregnancy. In 1967, a study raised initial concern that use of HPTs may be associated with birth defects. The then Committee on Safety of Medicines (CSM) kept this issue under review and in 1975 recommended that in view of the possible concern, and the availability of alternative methods, doctors should not use HPTs. These products were withdrawn from the market in the late 1970s.
In October 2014, the government committed to an independent review of the evidence relating to HPTs and the possible risk of birth defects. The review is not a political inquiry intended to demonstrate liability, but to examine the evidence to assess whether there are grounds for accepting a link between the use of HPTs and the conditions experienced by some patients.
A group of experts in relevant scientific disciplines is currently being convened to conduct the review, which is expected to be completed by the beginning of 2016.
To ensure all the available evidence is reviewed, the MHRA is currently in the process of obtaining all relevant documents. As part of this process, the MHRA is asking any individual or organisation with information they feel is relevant to submit it for consideration by the experts during the review. All evidence submitted will be included in the review and a report (including a public summary) will be made publicly available once the review is complete.
Dr June Raine, the MHRA’s Director of Vigilance and Risk Management of Medicines, said:
“We encourage people to send us any information they consider is relevant to previously used hormonal pregnancy tests and potential adverse effects that they think may have been associated with these drugs.
“It is important that we hear from people who feel they or their child have been affected adversely by hormonal pregnancy tests. We encourage anyone who wants to provide information about a suspected adverse effect from use of a HPT to submit it to us via a Yellow Card report.
“We would also welcome any other published or unpublished evidence you consider relevant and wish to submit for the review and ask that you send this to us by the end of June 2015. ”
Medicines regulator launches call for evidence on previously licensed oral hormonal pregnancy tests, MHRA press release, 25 March 2015.
You can report suspected side effects (also known as adverse drug reactions) to a medicine, vaccine, herbal or complementary remedy through the Yellow Card Scheme. The scheme, run by the Medicines and Healthcare products Regulatory Agency (MHRA) and the Commission on Human Medicines, is used to collect information from both health professionals and the general public on suspected side effects. a Video by MHRAgovuk, Published on 1 Apr 2014.
UK meds regulator destroys detailed information on the benefits and harms of drugs it has approved after it has held it for 15 years on file
BRITAIN’S medicines regulator has destroyed the original scientific data supporting the licensing of Prozac, the antidepressant drug that is provoking growing controversy over evidence that it is linked to suicide.
It means that scientists who have tried to re-examine the evidence justifying its release may now never be able to find out how good the science was. Patients making compensation claims will face the same problem.
The UK medicines regulator destroys detailed information on the benefits and harms of medicines it has approved after it has held it for 15 years. This means that for medicines which have been on the market for longer than 15 years, which is the majority of them, the Medicines and Healthcare Products Regulatory Agency (MHRA) no longer holds the data it based its licensing decision on.
This came to light after Professor Peter Gotzsche, co-founder of the Cochrane Collaboration, asked the European Medicines Agency for the data used to support the licensing of the antidepressant Prozac (fluoxetine). Gotzsche was referred to the MHRA as the UK is designated as the Reference Member State for Prozac meaning the MHRA is the nominated body within the EU that holds the information on the drug. Never the less, the MHRA had shredded clinical evidence about the benefits and harms of the product. It told Professor Gotzsche “Under MHRA record management policy, all application files and data for licences are held for 15 years. After this period, files are destroyed unless there is a legal, regulatory, or business need to keep them, or unless they are considered to be of lasting historic interest.”
The Sunday Times reported yesterday that “the MHRA said it had shredded the detailed information and held only some documents that summarised the findings. Eli Lilly, the manufacturer, retains the data and the MHRA said it can order it to be submitted.”
Professor Gotzsche wrote in a letter in the BMJ in June 2011 “As citizens in the EU, we should not accept this state of affairs. … The UK government should introduce legislation that will prevent the MHRA in future from destroying the evidence in its possession.”
Dr Ben Goldacre, co-founder of AllTrials said: “The MHRA needs to recognise that the world has changed, it is no longer acceptable for decisions about medicines to be based on secret meetings, about secret information that is then shredded. Doctors, researchers and patients need access to all the evidence, to make fully informed decisions about which treatment is best, and help spot problems with treatments as quickly as possible. Science progresses, and medicine improves, when we have many eyes on the data.”
MHRA shreds clinical trial info after 15 years, AllTrials.net, News release, 24th March 2014
More information, letters, opinions and articles:
Drug regulator destroys Prozac research, TheSundayTimes, 23 March 2014