Tag: Testing | Pharmacy in Practice

NHS Scotland invest £6.76 million in COVID-19 rapid antigen testing

NHS Scotland has agreed a £6.76 million deal to purchase new machines capable of turning around coronavirus (COVID-19) tests in 12 minutes.

The test detects COVID-19 antigen protein from a nasal swab with results in under 12 minutes in symptomatic patients. Other rapid tests currently being trialled produce results in an average time of 90 minutes.

UK-based life sciences company LumiraDx will supply 300 rapid testing machines as well as a minimum of 500,000 tests. Test strips for the small portable machines will be made at the company’s facility in Stirling.

The LumiraDx Platform instruments can be used anywhere and have been designed to meet needs in more remote locations making them ideal for local clinics or mobile units in Scotland’s rural and island communities.

Because the instruments connect to a cloud system, outbreaks of COVID-19 can be tracked quickly by health authorities playing a vital role in Scotland’s Test and Protect strategy.

The test was authorised for emergency use by the US Federal Drug Administration last week and is going through the final stages of validation for use in Scotland and Europe. LumiraDx is UK-based with headquarters in London, research and development and manufacturing in Stirling and sales offices in Arbroath.

Following the initial order of 500,000 tests the Scottish Government anticipates a four nations agreement for future procurement.

Ivan McKee, Minister for Trade, Investment and Innovation, said:

“The contract with LumiraDx to supply 12-minute test instruments to NHS Scotland is great news for communities across the country and for the global fight against this virus.

“The strips that are part of these testing devices will be manufactured in Scotland supporting local jobs and again highlighting the strength of our life sciences industry.

“Our vision is for a Scotland where innovation is an intrinsic part of our culture, our society and our economy and this is one example of the role that our life science sector can play on the global stage.”

Chief executive and chairman of LumiraDx Ron Zwanziger said:

“We designed our high-sensitivity Platform to deliver fast, accurate and actionable diagnostic results near to the patient.

“We are proud to have a strong presence in Scotland with our research and manufacturing teams here and look forward to working with Scotland’s health systems to address the COVID-19 crisis in a way that’s affordable and accessible in community care settings.”

This circular is being shared under the Open Government Copyright licence.

Pharmacy bodies comment on rapid antibody testing

In response to the news that the General Pharmaceutical Council has advised against the use of COVID-19 rapid antibody tests the following pharmacy representative bodies provided comment to PIP on the topic.

Community Pharmacy Scotland Director of Operations Matt Barclay commented:

“CPS acknowledges the GPhC position on the sale of rapid antibody tests. We also note that this is consistent with the current position of Scottish Government as highlighted in June by the CMO, which highlights that these tests are only being used for surveillance measures across the Scottish population. We would, therefore, encourage members to consider these positions with regard to the tests before making any decision about availability to the public at this time.”

Director of Operations and Support at PSNC, Gordon Hockey said:”

The letter from GPhC should be helpful to contractors and pharmacists alike, as with any advice from your regulator. Patients and members of the public rely on the professionalism of sector and while the GPhC may not deal directly with this particular legislation, it does deal with fitness to practise of the pharmacy team and the registration of pharmacies.”

An NPA spokesperson said:

“The NPA is in active discussions with manufacturers, regulators and Public Health England about antibody tests. More clarity is needed about the evidence base underpinning the current guidance which states that it is inappropriate for pharmacists to recommend or sell tests. We continue to believe that there should be a significant role for community pharmacy in the testing programme for COVID-19.”

A representative from the Royal Pharmaceutical Society (RPS) commented:

“RPS has provided guidance to support pharmacists and their teams on the frontline here based on the currently available evidence. Provision of COVID-19 testing as either private or NHS services should be in line with current evidence-based protocols using approved products and taking into account regulatory and RPS professional guidance. As the evidence around rapid COVID19 antibody testing develops, this position may change.”

You can read the letters to the editor on this topic here.

Pharmacies should be allowed to supply rapid antibody tests

In response to the following article:

“GPhC tell pharmacies to stop selling rapid antibody tests”

Dear PIP editor,

I do not agree with the statement made by the GPhC suggesting that COVID-19 rapid antibody tests should not be supplied by community pharmacies across the country.

I think that the evidence supporting the use of these COVID-19 rapid antibody tests is strong enough to support their use.

More confusing and inappropriate advice from the GPhC. It’s frankly outrageous and behind the times in my opinion.

The Biopanda tests, marketed by PharmDoctor I use are CE certified and approved by the MHRA for use by healthcare professionals such as pharmacists. They are not the same as the finger-prick lab-based tests which were being illegally sold by others.

When carrying out the antibody testing service, we ensure patients are informed about the limitations of the tests and ensure the patient knows that regardless of the test result (+ve or -ve) that it has no relation to immunity and that the patient must continue following the government’s advice to continue social distancing and isolate if required.

This service enhances the reputation of the community pharmacist. Too many times we have been told that all we do is dispense prescriptions and now we were able to offer something new, different and innovative. This is something that people want and then our regulator arbitrarily says it shouldn’t be done.

Nonsense and farcical.

I think the step the GPHC has taken is an easy decision in order not to have to oversee this in any way shape or form. Especially at a time where premises and pharmacist registration fees are increasing by 50%, there is no excuse for GPhC Inspectors not to engage with the profession and support us in delivering a better and more complete service.

Other professions such as nurses and doctors have not been told to stop doing antibody tests so perhaps what the GPhC is saying is that pharmacists are not capable of delivering a healthcare message. Instead, we are only good at doing what machines will do in the future or more worryingly Amazon pharmacy will do soon.

I think the GPHC is at risk of bringing the profession into disrepute with members of the public who has clearly enjoyed discovering what the pharmacist can really do and are really about.

Also, I think that the GPhC is implying that people are too stupid to understand what having a test done means and frankly the insults that they have inflicted on community pharmacy have now been extended to members of the public and that is shameful.

The GPhC is clearly out of touch with the real world. Not for the first time.

Yours etc.

Anon.

This letter was submitted by a community pharmacist who wished to remain anonymous.

PharmaDoctor™ defend their position on rapid antibody tests

PharmaDoctor™ has responded to the recently published statement by the General Pharmaceutical Council (GPhC) advising pharmacy owners and superintendent pharmacists against the supply of COVID-19 rapid antibody tests through community pharmacy.

The response from PharmaDoctor™ in the form of an open letter to the GPhC is outlined below.

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To access further supporting documents PharmaDoctor™ has asked that you contact them directly. You can access their website here.

Have your say and write to the editor. With your permission, we will publish your thoughts in our ‘letters to the editor’ section.

GPhC tell pharmacies to stop selling rapid antibody tests

In a letter to pharmacy owners and superintendent pharmacists in the UK, the General Pharmaceutical Council (GPhC) has said that it is inappropriate for community pharmacies to sell COVID-19 rapid antibody tests.

The GPhC has stated that:

“At this point in time, we do not regard it as appropriate for community pharmacy to be selling and recommending rapid antibody test kits.”

The letter says that although the GPhC does not have jurisdiction over the legality, safety or efficacy of particular types of tests or kits, it does have a responsibility as the regulator of pharmacy professionals, in relation to the standards that must be met by pharmacists and pharmacy technicians in all settings in which they work, and the standards that must be met by the owners of registered pharmacies.

The GPhC has drawn attention to the fact that they expect pharmacists and pharmacy technicians, and those who own pharmacy premises, to protect public health at all times. This includes following guidance from bodies like Public Health England and others.

Chief Executive and Registrar of the GPhC Duncan Rudkin commented:

“I want to highlight our position concerning the provision and sale of COVID-19 rapid antibody tests from community pharmacies: in the light of current public health advice, it is not appropriate for them to be sold in community pharmacies or recommended by pharmacy professionals at this point in time.

“We are aware that there are manufacturers selling and supplying COVID-19 rapid antibody testing kits and that these tests are being offered privately in several community pharmacies across Great Britain.

“Although it may be legal to sell or supply a product, for example, it may have a CE mark this does not necessarily mean that it is appropriate for a health professional to supply it to a patient or member of the public. We would expect all pharmacy professionals to consider the wider public health impact. During this ongoing national public health crisis, any activity that may contribute to false results or assurances that then impact on public behaviour should not be supported.

“Both the World Health Organisation and SAGE, the Scientific Advisory Group for Emergencies, have advised there are potentially negative impacts on public health if individuals assume immunity from a positive result and adapt their behaviour in a way which could increase the risk of continued transmission.

“To date we have:

Worked closely with other regulators and public health agencies which have leading roles to play in relation to testing and test kits, to identify the latest guidance and information in this fast-moving area.

Shared this guidance and information with stakeholders, members of the public, pharmacy professionals and pharmacy owners, including through our coronavirus Q&A.

When made aware that a pharmacy is providing tests which do not adhere to guidance from the public health agencies in Great Britain, written to the pharmacy to tell them to stop providing these tests. Our inspectors have been signposting pharmacy owners, superintendent pharmacists and pharmacy professionals to relevant guidance and reiterating our position on this.

“Overall, we want to reiterate that, at this point in time, we do not regard it as appropriate for community pharmacy to be selling and recommending rapid antibody test kits. The UK Government as well as the Scottish and Welsh Governments, alongside the key public health bodies, WHO and SAGE have all intimated that:

Their use in the response to COVID-19 has not yet been established.
That that there is conflicting evidence in relation to the use and efficacy of these tests.
The public health consequences potentially outweigh any benefit a patient or member of the public may gain from this type of.

“We are asking that you ensure your pharmacies support public health by not offering such services and stopping any current provision. We are aware that this is a fluid landscape and we will continue to work closely with other regulators with leading roles in relation to testing and provide an update if the situation changes.”

Chief Executive of PharmaDoctor™ Graham Thoms commented:

“As the leading provider of antibody tests to community pharmacy, we are not aware of any pharmacies selling test kits to members of the public.

“Over 510 pharmacies are however offering a clinically robust Antibody Testing SERVICE using CE Certified tests which were approved for sale by the MHRA for healthcare professional use on the 5th March.

“PharmaDoctor™ wrote to Public Health England (PHE) three months ago so far with no response. We asked them to update their advice (not updated since first published 25th March) which states that they can’t be sure of the ‘accuracy of antibody tests to diagnose COVID-19 infection’.

“We all know that antibody tests don’t ‘DIAGNOSE’ COVID infections, that’s the job of the antigen tests, not the antibody tests. The antibody testing service being offered in over 510 UK pharmacies with the support of PharmaDoctor™ ensures customers using the service understand the limitations of the tests and that a positive result doesn’t equate to immunity against COVID.

“The service also enforces the need to continue following government advice with regards to social distancing and isolating if appropriate.

“Come on PHE and GPhC.. let’s have a constructive discussion…?”

You can read the letter in full here.

Have your say and write to the editor. With your permission, we will publish your thoughts in our ‘letters to the editor’ section. We invite you to reference any relevant evidence to support your opinion.

Scottish Ambulance Service to take over mobile testing sites

The Scottish Ambulance Service (SAS) will take over the running of Scotland’s coronavirus (COVID-19) mobile testing units from the start of September.

Currently operated by HM Armed Forces, the mobile units will pass to SAS, where they will continue to support the ongoing response to the COVID-19 pandemic, including the management of localised outbreaks.

The units complement the static drive-through testing centres and testing in hospitals and care homes and help ensure that testing is as accessible as possible for everyone. There are currently 13 mobile testing units in Scotland, with this due to rise to 18 by July 15, 2020.

As part of the transfer, around 500 positions will be created across the country for as long as the service is needed. Recruitment for these new posts has started, with the majority of roles being recruited from outside the Ambulance Service.

Health Secretary Jeane Freeman said:

“I want to thank the Armed Forces personnel who have been running the mobile testing units in Scotland since they were set up in April.

“Transferring operational delivery to the Scottish Ambulance Service will help to ensure that mobile testing units continue to support testing in local communities and provide a sustainable, long-term response to the pandemic.

“The units play an important role in NHS Scotland’s Test and Protect programme which is controlling the spread of COVID-19 in the community.

“But to help that work, it is vital that everyone who has symptoms isolates and books a test immediately. Continuing to supress the spread of the virus is the goal we all share.

“NHS Scotland’s Test and Protect has a crucial and central role in protecting all of us and will help to ensure we move through the phases of the lockdown exit strategy. It is a collective effort to help us protect others and save lives.”

Pauline Howie, Chief Executive of the Scottish Ambulance Service, said:

“Our staff have done a tremendous job throughout the pandemic, working hard to keep patients safe, and we will recruit staff to extend our Service to support the crucial Test and Protect programme.

“Our staff work at the heart of all Scotland’s communities, so using us to take COVID-19 testing forward makes good sense – not only can we maintain the high standards set by the Armed Forces, we can ensure people continue to get good quality face-to-face assistance.”

Brigadier Robin Lindsay, Joint Military Command Scotland said:

“The Armed Forces have been proud to provide support to the Scottish Government’s fight against COVID-19 over the last few months, across a range of different planning, supply and delivery tasks, including staffing the Mobile Testing Units (MTUs) across Scotland. The Armed Forces will continue to work with our Scottish and other partners to ensure a smooth handover of this vital work.”

This circular is being shared under the Open Government Copyright licence.