Press release: MHRA recalls Valsartan blood pressure and heart medication from pharmacies

The Medicines and Healthcare products Regulatory Agency (MHRA) are undertaking a pharmacy level recall of all affected batches of Valsartan containing medicines made by Mylan and Teva as a precautionary measure.

This follows an earlier pharmacy level recall in July, when MHRA recalled affected batches of valsartan containing medicines from Dexcel and Actavis (now Accord), also to pharmacy level.

That recall occurred across Europe, following information that an impurity, N-nitrosodimethylamine (NDMA) was identified as part of the manufacturing process in a valsartan active substance manufactured at one facility based in China.

During the course of the investigation into NDMA, another impurity, N-nitrosodiethylamine (NDEA), was discovered in valsartan drug substance. MHRA, together with other EU regulators, are continuing to investigate other sartan products which share a similar chemical structure to valsartan.

At present there is no evidence that this impurity has caused any harm to patients. This recall is being undertaken as a precautionary measure to prevent further exposure to this impurity in the affected medicines whilst the investigation is ongoing. Due to the risk associated with suddenly stopping high blood pressure medication, people are therefore advised not to stop any treatments without consulting their doctor or pharmacist.

We are working closely with other EU member states, the European Medicines Agency (EMA) and the European Directorate for the Quality of Medicines (EDQM) to ensure a thorough investigation and we will consider the impact in the UK and what actions may be necessary.

Dr Sam Atkinson MHRA’s Director of the Inspection, Enforcement and Standards Division said:

Our highest priority is making sure the medicines you take are safe.

We are undertaking a pharmacy level recall of all affected batches of Valsartan containing medicines made by Mylan and Teva. This is a precautionary measure to prevent any further exposure to the impurity in the affected medicines whilst the investigation continues and further updates will be provided.

Because of the risk associated with suddenly stopping high blood pressure medication, people are advised not to stop any treatments without consulting their doctor or pharmacist.

We strongly encourage anyone taking valsartan medicines to report any suspected side effects, to us via our Yellow Card Scheme.

Please speak to your GP, pharmacist or any other healthcare professional if you take the affected medicines and they will be able to advise and answer any questions.

Notes to Editor

  1. MHRA is responsible for regulating all medicines and medical devices in the UK. All our work is underpinned by robust and fact-based judgments to ensure that the benefits justify any risks. MHRA is a centre of the Medicines and Healthcare products Regulatory Agency which also includes the National Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD). The Agency is an executive agency of the Department of Health. www.mhra.gov.uk

  2. Link to Yellow Card Scheme

  3. Link to Drug Alert




News story: Alert for charities – fundraising and postal stamp fraud

Stamp fraud involves the preparation, distribution and sale of previously used stamps for reuse. Usually these stamps are sold online, at a lower price than the standard postal service rate.

Anyone knowingly collecting, preparing, distributing, reusing or selling used stamps to avoid paying full postal fees may be committing a form of fraud.

How it can impact charities

A number of charities collect used stamps as a means of fundraising.

Although we do not believe that charities are knowingly profiting from the collection and sale of used stamps, some are inadvertently enabling this form of fraud by selling packages of used stamps, commonly referred to as ‘kiloware’.

The majority of these stamps are then prepared and fraudulently re-sold as if they were valid postage. The money being made by criminal gangs from this type of fraud is significant, and can be used to fund further and wider scale criminal activity.

Fundraisers may believe they are selling stamps to collectors but this is rarely the case as these stamps have little collectable value.

Charities should avoid engaging in this activity unless they are certain that the stamps collected and sold are genuinely being bought by collectors, and are not being used for fraudulent purposes.

Warning signs to look out for

Signs that a potential buyer of used stamps may not be a genuine collector include:

Requests to bulk buy

Be wary of requests from individuals to purchase UK or GB ‘kiloware’ from you in bulk. Genuine collectors tend to have their own sources of used stamps and often trade with each other – it is unlikely that they would specifically call on charities to provide loose stamps.

Requests for certain types of stamps

There is no reason for any genuine dealer to request previously used, uncancelled stamps, ‘Non Value Indicator’ stamps (do not display a price), or Christmas stamps in bulk. An uncancelled stamp is one which has been through the postal system, but hasn’t been marked as used. It is often incorrectly referred to as unfranked.

Offering to deal stamps on your behalf

Some stamp collectors may genuinely request foreign or specialist stamps but charities should consider a company or person offering to deal stamps on their behalf as a potential red flag.

All of the above examples put your organisation at risk of being unwittingly involved in a form of fraud that is potentially funding wider scale criminal activity.

How to protect your charity from stamp fraud

  1. Decline requests from individuals or groups who wish to purchase used GB stamps from you directly – either through direct contact or via your online marketplace. Additionally, let Royal Mail know if you suspect that a request may not be from a genuine dealer.

  2. If you are satisfied that your stamps are destined for collectors, check the type of stamps you are collecting. Foreign stamps are less likely to be fraudulently sold in the UK.

  3. Consider checking that your charity name is not being used in ‘kiloware’ advertising without your permission.

  4. If you buy stamps for your charity’s own use then buy them from the Post Office or any other reputable seller. Stamps are typically not sold at a discounted price.

How to report fraud

To report suspected stamp fraud, and for more information on the subject, please visit the Royal Mail website.

If your charity becomes a victim of insider fraud, or any other type of fraud, report it to Action Fraud by calling 0300 123 2040, or by visiting the Action Fraud website.

Charities affected by fraud should also report it to the Charity Commission as a serious incident, using the dedicated email address rsi@charitycommission.gsi.gov.uk

Serious incident reporting helps us to assess the volume and impact of incidents within charities, and to understand the risks facing the sector as a whole. Where appropriate, we can also provide timely advice and guidance.

Notes

The Charity Commission, the independent regulator of charities in England and Wales, is issuing this alert to charities as regulatory advice under section 15(2) of the Charities Act 2011.




Press release: Prime Minister Theresa May becomes first PM to visit Buenos Aires

Prime Minister Theresa May will today tell world leaders that the Brexit agreement reached with the EU is ‘a good deal’ for the global economy.

Speaking at a session on trade at the G20 in Buenos Aires the PM will say that the UK will be able to ‘play a full and active role on trade on the global stage, working with friends new and old’.

The PM will also hold a series of bilaterals with world leaders over the course of the Summit.

At the trade session, she will say the agreement reached between the UK and the EU last Sunday will have positive consequences for the world economy.

The PM will tell fellow leaders:

Our relationship with the EU will remain close. A free trade area with no tariffs, fees, charges, quantitative restrictions or rules of origin checks, will protect jobs, including those that rely on integrated supply chains.

International firms that have invested in UK production or use European bases to supply the UK market will benefit from these arrangements.

But we will be leaving the EU, including the Single Market, the Customs Union, the Common Agricultural Policy and the Common Fisheries Policy.

For the first time in more than four decades, the UK will have an independent trade policy. We will play a full and active role on trade on the global stage, working with friends new and old, at a time of unprecedented global interconnectedness.

From April 2019 the UK will take up its independent seat at the WTO, representing ourselves and using our voice to advance UK interests and support the multilateral trading system while respecting the principle of sincere cooperation.

On Friday the PM will discuss ways in which to boost bilateral trade and investment with President Macri of Argentina, which is Latin America’s third biggest economy.

The leaders are expected to agree the first ever UK Trade Envoy for the country.

The PM’s visit is a significant milestone, marking the first time a British Prime Minister has ever travelled to Buenos Aires and only the second Prime Ministerial visit to Argentina after Tony Blair in 2001. It comes just days after the UK and Argentina announced the agreement of a new flight between Latin America and the Falklands, underlining the progress that has been made in the relationship.

The PM and President Macri will talk about co-operation on shared priorities such as international security.

The G20 also marks the PM’s first visit to Latin America, which has been identified as an increasingly important partner for the UK’s global ambitions post-Brexit.

Latin America is the fourth largest market in the world with 638m people, a combined GDP of $5.6tn, falling poverty levels and a growing middle class population.

Net UK investment is already growing strongly, more than doubling in Brazil since 2010 from £6.4bn to £15bn.

At the Summit the Prime Minister will also discuss with President Pinera of Chile the good progress being made towards transitioning our current trade arrangements with Chile. This is one of a number of EU trade agreements that the UK is working with partners across Latin America to transition.

In advance of the visit, the PM said:

The Brexit deal we have agreed sets a path for the UK to a brighter future. The announcement of a new Trade Envoy for Argentina and progress in transitioning our trade agreement with Chile show that we are already taking significant steps to boost trade in fast-growing new markets.

We have strong links to build on – British energy companies are on the ground in Argentina, working to develop local energy sources, while financial services firms supports the funding of these projects to expand Argentinian infrastructure. In my discussions with President Macri we will be exploring how we can develop this further for the prosperity of both our countries.




News story: Smart-city modeller wins data pioneer of the year award

Insights and predictive analytics company, Citi Logik, has won the data pioneer of the year’ award at the 2018 UK Business Tech Awards, following a series of projects that assist urban planners.

Its technology – CitiAnalytics – creates a detailed analysis of road and transport movements using anonymised 3G and 4G mobile network data. It then provides a transport model to help with future infrastructure planning and development around vehicles, walking and public transport.

Citi Logik Chief Executive Officer, Stephen Leece said it’s important that companies that use data for public good are recognised:

We’ve taken a very specific decision to work in a very precise area of the smart city market, by working with data for a public benefit.

The award is recognition that that’s a good thing to do and that this is the way forward for managing data.

Ongoing support

Citi Logik has benefitted from various funding and support from Innovate UK.

In 2011, small-scale grants from Innovate UK and Transport for London led to high-profile contracts to analyse traffic flows around the Heathrow and Gatwick airports.

Further funding in 2017 enabled the company to test its platform in a real-world environment with the city of Hull.

This year the company received an innovation loan – Innovate UK support designed for businesses close to market – to help them commercialise their innovation.

New contracts, new projects

Citi Logik, which is now based out of the Future Cities Catapult in London, has followed its success at the UK Business Tech Awards with new contracts to evaluate the core data of travel models in 2 cities in Yorkshire and the north east.

The first will provide a similar model to the Hull project, using anonymised mobile data, while the second will look at air quality.

Stephen continues:

Local authorities are now mandated to identify areas that need attention and they need a plan to reduce the impact.

We’ll be providing statistical data of people’s movements by their own vehicles, foot and public transport to help them build a strategy based around it, whether that’s persuading people to take different routes or to charge vehicles within certain zones.

The UK Business Tech Awards feature 18 categories across various disciplines including education technology, finance technology, best app and entrepreneur of the year. Citi Logik was 1 of 6 companies shortlisted for the data pioneer of the year award.




News story: Carprieve Small Animal Injection – Product defect recall alert

Carprieve Small Animal Injection

Norbrook Laboratories Ltd is recalling the below mentioned batch from the market place as a precautionary measure as sterility cannot be assured.

Batch Expiry Date
8254-90G 21/06/2020

Norbrook is contacting vets and wholesalers to examine inventory immediately and quarantine products subject to this recall.

Should you have any questions, please contact Ms. Naomh Thompson (0044 2830264435) or alternatively by email to naomh.thompson@norbrook.co.uk

Published 30 November 2018