MHRA reassure public on AstraZeneca vaccine

 

Following suspensions by some countries of the COVID-19 Vaccine AstraZeneca over suspected blood clots, the MHRA confirms that the benefits of the vaccine in preventing COVID-19 far outweigh the risks. People should still go and get their COVID-19 vaccine when asked to do so.

 

The UK regulator, following a rigorous scientific review of all the available data, said that the available evidence does not suggest that blood clots in veins (venous thromboembolism) are caused by COVID-19 Vaccine AstraZeneca. This follows a detailed review of report cases as well as data from hospital admissions and GP records. This has been confirmed by the Government’s independent advisory group, the Commission on Human Medicines, whose expert scientists and clinicians have also reviewed the available data.

 

The MHRA’s advice remains that the benefits of the vaccines against COVID-19 continue to outweigh any risks and that the public should continue to get their vaccine when invited to do so.

 

Dr June Raine, MHRA Chief Executive, said:

 

“We continually monitor safety during the use of all vaccines to protect the public and to ensure the benefits continue to outweigh the risks.

 

“Our thorough and careful review, alongside the critical assessment of leading, independent scientists, shows that there is no evidence that that blood clots in veins is occurring more than would be expected in the absence of vaccination, for either vaccine.

 

“We have received a very small number of reports of an extremely rare form of a blood clot in the cerebral veins (sinus vein thrombosis, or CSVT) occurring together with lowered platelets soon after vaccination. This type of blood clot can occur naturally in people who have not been vaccinated, as well as in those suffering from COVID-19.

 

“Given the extremely rare rate of occurrence of these CSVT events among the 11 million people vaccinated, and as a link to the vaccine is unproven, the benefits of the vaccine in preventing COVID-19, with its associated risk of hospitalisation and death, continue to outweigh the risks of potential side effects.

 

“You should therefore continue to get your jab when it is your turn.

 

“While we continue to investigate these cases, as a precautionary measure we would advise anyone with a headache that lasts for more than 4 days after vaccination, or bruising beyond the site of vaccination after a few days, to seek medical attention.

 

“However, please remember that mild flu-like symptoms remain one of the most common side effects of any COVID-19 vaccine, including headache, chills and fever. These generally appear within a few hours and resolve within a day or two, but not everyone gets them.

 

“We will continue to robustly monitor all the data we have on this extremely rare possible side effect.

 

Professor Sir Munir Pirmohamed, Chair of the Commission on Human Medicines, said:

 

“The independent COVID-19 Expert Working Group of the Commission on Human Medicines, together with leading haematologists, conducted a rigorous analysis of all available evidence regarding reports of blood clots (thromboembolic events) and COVID-19 Vaccine AstraZeneca.

 

“Our review has found that the available evidence does not suggest that blood clots are caused by COVID-19 Vaccine AstraZeneca.

 

“We have been closely reviewing all reports of blood clots in the vein (venous thromboembolism, or VTE) following vaccination. There is no evidence either that VTE is occurring more often in people who have received the vaccine than in people who have not, for either vaccine.

 

“However, we will continue to closely monitor the reports where cerebral sinus venous thrombosis has occurred in conjunction with lowered platelets to understand whether there is any potential association. This type of blood clot can rarely occur naturally in unvaccinated people as well as in people with COVID-19 disease. In the UK, 5 possible cases of this have been reported to us so far, after 11 million doses of COVID-19 Vaccine AstraZeneca.

 

“Further work with expert haematologists is underway to further understand the nature of these cases and whether there is a causal association with any of the vaccines. Given the extremely rare rate of occurrence of these events, the benefits of the AstraZeneca COVID vaccine, with the latest data suggesting an 80% reduction in hospitalisation and death from COVID disease, far outweigh any possible risks of the vaccine in the risk groups currently targeted in the UK.”

 

Royal Pharmaceutical Society Chief Scientist Professor Gino Martini said:

“I hope that any concerns about potential links between the Oxford-AstraZeneca COVID-19 vaccine can now be discarded given the positive verdicts delivered by the EMA, the WHO and the MHRA, who have all now said the is safe, effective and can continue to be used. The vaccine is playing a crucial role in protecting vulnerable groups from hospitalisation and death and helping to decrease infection rates across the UK.

“The MHRA is renowned as a world-class regulator of medicines and vaccines. They are continuing to monitor the Oxford/AstraZeneca vaccine closely as part of a ‘rolling review’ approach to COVID-19 jabs, through rigorous checks and processes, at they would for any other vaccine or medicine.

“As trusted health professionals, pharmacists are playing a key role in administering COVID-19 vaccinations and have contributed enormously to the success of the programme so far. We have full confidence in these vaccines and can confidently state that pharmacists can continue administering them to patients. It is so important that we get all those at risk from the virus vaccinated as soon as possible.”

 

Elements of this article are being shared under the Open Government Copyright licence.

 

 

NI pharmacies join vaccination programme

 

Community pharmacies across Northern Ireland will join the Covid-19 vaccination programme from the end of this month, Health Minister Robin Swann has announced.

 

The plan will see hundreds of community pharmacies provide vaccine jabs to members of the public, complementing the work of GP practices and vaccination centres. Over 300 pharmacies have signed up to be part of the scheme to date.

 

The official launch of the roll-out to community pharmacies will be on March 30th, although it is expected that many will have started before then.

 

The Health Minister said:

 

“I am delighted to confirm yet another positive development in our drive to protect the people of Northern Ireland from Covid-19.

 

“Community pharmacists are an integral part of the health and social care family. Their contribution to getting as many people vaccinated as possible will be invaluable.”

 

Northern Ireland’s Chief Pharmaceutical Officer Cathy Harrison said:

 

“Community pharmacies are the most accessible healthcare service for the public and their involvement in the Covid-19 vaccination programme will build on the success of their role in Northern Ireland’s 2020/21 winter flu vaccination.

 

“I want to thank all the pharmacy staff involved and representatives of the community pharmacy sector for their support in bringing this plan to fruition.”

 

Joe Brogan, Head of Pharmacy and Medicines Management at the Health and Social Care Board, said:

 

“The Covid vaccination campaign is one of the ways that we as a society will move forward. It is vital that our population has every opportunity to access this service and it’s fantastic to have over 300 further points where people can book an appointment for a vaccine at a time and a place that suits them. I wish to recognise the tremendous response of community pharmacy teams in supporting the response to Covid and our pathway out of the pandemic.”

 

The Chief Executive of Community Pharmacy NI, Gerard Greene, said:

 

“This is a fantastic and welcome step forward. The accessibility and reach of the community pharmacy network, with pharmacists as skilled vaccinators, means they are well equipped to take part in the vaccine programme and further contribute to the pandemic response.

 

“Throughout the pandemic, the community pharmacy workforce has gone above and beyond to support patients across Northern Ireland. This latest example shows our pharmacists collaborating to ensure a smooth and safe vaccine programme to protect the public. This should be commended.

 

“We would also remind the public that community pharmacies remain open with support and guidance for any medical concern. The vaccination programme will not impact on other services and prescriptions will be dispensed in a safe, convenient and timely manner. Public health continues to be our top priority and the community pharmacy network remains committed to serving their communities. The Covid-19 vaccine is another example of community pharmacy playing that central role in primary healthcare.”

 

 

Could IR35 be good for pharmacist locums?

 

I have to say I’m getting a bit concerned about the lack of discussion around pharmacist locums and IR35.

 

From the 6th of April, the choice about whether you are working inside or outside IR35 no longer lies with the pharmacist locum trading as a limited company, but with the end-user, i.e. the pharmacy contractor. This will fundamentally change the way locum pharmacists work and trade, so you must understand the extension of IR35 into private companies -similar rules have applied in the NHS since April 2017.

You can access the tool for checking employment status by clicking here.

 

I think the expectation was that the extension of IR35 into the private sector wouldn’t happen, but all indications are that it will. The new Chancellor, Rishi Sunak, has suggested a gently, gently approach, but in my experience, HMRC will see this opportunity to gather more tax money and quickly.

Summary of what’s happening with IR35 from the Recruitment and Employment Confederation

 

What?

 

The Government is extending the off-payroll rules, which have applied in the public sector since April 2017, into the private sector. The new rules will apply to work done by contractors working through intermediaries such as personal service companies. Importantly, the tests for IR35 status is not changing, but the responsibilities for making the status decision and related deductions are.

 

When?

 

The new rules will apply to all payments made to personal service companies on or after 6th April 2021.

 

What’s the difference?

 

From 6th April 2021, the client, and not the contractor, will be responsible for assessing IR35 status. For inside IR35 assignments, the fee-payer will have to make tax and national insurance deductions before paying the personal service company.

 

My advice for all locums is to complete the online test via the link above then talk to your accountant. This is not the time to stick your head in the sand because not spending time to understand your personal position regarding IR35 could leave you with a huge tax bill.

Following the budget on 3rd March 2021, it is clear that IR35 will come into effect on 6th April 2021. The PDA has published a really helpful, considered article on the IR35 issue, which can be found here.

 

The NPA has also published guidance that is more geared to pharmacy owners and operators but it’s useful to understand the challenges that IR35 brings for pharmacies too. You can access this article here.

 

What now?

 

It’s really important that you take the time to understand your obligations and risks. You need to remember that you need to consider each arrangement you have with pharmacies individually.  After consideration of the increased complexity, it may be that you decide that locuming is no longer the right choice for you.

 

The irony is that the way locum pharmacists have worked and been booked has always been an anomaly when you compare it to other healthcare professions. The way that multiples have classically covered vacancies and holiday cover has never really made sense to me.

 

Why would you book locums by the day and not on longer-term, temporary contracts?

 

After all,  the pharmacy gets the consistent cover and the pharmacist can earn a premium for this consistency and earn holiday pay too? It may be that IR35 is the catalyst for change that benefits locum pharmacists in the long run.

 

Shaun Hockey is the Managing Director of Medacy Healthcare Support Solutions.

 

Please note that this article is not advice. You should seek advice from registered tax professionals or accountants who are qualified to give such advice.

 

Read more

 

Will IR35 change locum life forever?

 

Is IR35 a potential tax time-bomb for pharmacist locums?

The great patient medication returns debacle

Johnathan Laird Serial Nudger

 

The amount of money drained from the NHS via the oversupply of medication must be staggering and largely unmeasured.

 

I’m talking about the at times mountainous piles of returned medicines that get handed into community pharmacy for disposal.

 

The great patient medication returns debacle.

 

If you’ve ever worked in community pharmacy you’ll know the routine. The bin bags approaching up the middle aisle usually unfortunately from a bereaved close relative. In my experience, these great excesses of prescription drugs handed back to the community pharmacy usually come to light after the passing of a patient. The sadness of the moment is balanced by the mortification of the family members returning said medicines.

 

The empathetic shake of hands happens as you try your best not to raise an eyebrow at the three bin bags of returned medication about to be handed over.

 

Insulin, inhalers and dressings are expensive patients returns but the winner is usually the unused diabetic test strips and lots of them.

 

This problem needs to be tackled. It’s a classic lose-lose situation all around.

 

At the beginning of my career, I really did get irate when this happened. And on occasion, I will admit this probably clouded my mood so that I did not provide the highest level of patient-centred care. These situations would often involve offering condolences which in my more formative years was difficult through a mist of outrage. I’m not really proud of these occasions because family members deserve the care of their community pharmacist at that moment shortly after a bereavement.

 

I’ve often wondered what the public would think if the amount of money that the NHS wastes in this way. What is the average prescription item value these days? Something like £10-£12 per item? I honestly think the general public don’t have any idea about the scale of this problem. Perhaps putting the problem into context might help.

 

And on the flip side the problem really is conveniently difficult to measure because the system assumes that every patient will be adherent to their medication all of the time.

 

Well as pharmacists we know that even the most engaged patients will struggle to achieve 100% adherence.

 

The causes will be multifactorial but no doubt free access to medicines drives a certain amount of volume. Market forces are at play too. There is also the trend towards ‘managed repeat’ services but that’s whole other opinion article altogether. I think any conversation about waste must bring the desire for pharmacy contractors to sign up loyal repeat prescription patients. A patient on a managed repeat prescription service will I’m told generate higher annual dispensing sales compared to those patients not using such a service. I guess it’s easy for me to pontificate given that I don’t currently own a community pharmacy that still depends on prescription volume for profit.

 

One of the reasons I decided to write this article was the link from this topic I made with the charge that was initiated for plastic bags supplied from retailers in recent years.

 

I remember working in a community pharmacy in Scotland when the plastic bag charge was initiated. I found it absolutely hilarious the lengths some folk would go to to avoid the 5p investment in a bag to ensure their walk to the car was comfortable. Instead that first year there was some heroic resistance to splashing out on the bag charge. Things have moved on from then because any form of the plastic bag would surely be frowned upon now due to environmental considerations.

 

Now that’s all very interesting to you I’m sure but the bottom line about the plastic bag charge idea was that it actually worked. The number of bags used by the pharmacy absolutely plummeted. I’m guestimating here but I’d say in the six months after the charge came in the usage of plastic carriers bags in the pharmacy dropped by as much as 80%.

 

The difference before and after implementation of the charge was stark.

 

I think that was probably an example of nudge theory. I highly recommend the book, surprisingly called ‘Nudge’, where these ideas have been articulated.

 

The first chapter of that book involves a little story about a school headmaster. Basically this headmaster was tasked with improving the levels of healthy eating amongst the youngsters at lunchtime. The headmaster was given no extra budget and his brief required student choice to be respected. His solution was to rearrange the cafeteria. He put the fresh fruit, veg and healthy options at the front and the chips, burgers and other less healthy options behind the screen at the far end of the room.

 

Much like in the plastic bag example the plan worked and he began to ‘nudge’ the children towards making healthier options.

 

So what is the ‘nudge’ solution that could be applied to our patient medication return problem?

 

Well unlike our headmaster striving for healthier eating choices we can’t really make it more difficult for patients to access or re-order their medicines in the first place but perhaps we could disincentivise it. At the very least I’d like to support patient education to such an extent that the decision to order is at least considered. There has always been the argument that some kind of charge on prescriptions would be draconian and to be honest I agree.

 

But the lever in the plastic bag success story was a monetary one albeit a very low-level charge. Perhaps the solution could be something simple like making the price of the medicine really clear to our patients or enforcing a nominal 5-10 pence charge per item.

 

I’m not sure what the answer is but what I am fairly sure of is that things can’t get much worse. Wouldn’t it be great if we could stumble upon a low cost ‘nudge’ type solution that tackles this issue once and for all?

 

This amount of waste has to stop so come on clever people answers on a postcard, please.

 

Johnathan Laird is a pharmacist who likes to think he is a serial nudger but probably often doesn’t realise he himself is being nudged.

 

 

 

Andrea James on the legal impact of COVID-19 on pharmacy

 

Our guest for this podcast is Andrea James. Andrea is a regulatory lawyer advising doctors, pharmacists, vets, teachers & other highly regulated professionals.

 

She also loves animals, laughter and fairness.

 

Andrea is a partner at Brabners. She leads their Professional Discipline and Healthcare Regulatory team, providing vital insight to our wider Regulatory team and Healthcare sector group. You can contact Andrea to engage her services by clicking here.

 

In the first of two podcasts, we discussed how the recent fast-moving legislative changes and action by the GPhC may impact on the practise of pharmacy in the UK.

 

  • Is there temporary deregulation of the pharmacy happening at the moment?
  • What advice do you have for pharmacists having to make difficult ethical professional decisions?
  • What advice would you give to pharmacists making a difficult ethical professional decision?
  • How do you think things will change the new era after COVID-19?

 

 

We discussed and recommended the Royal Pharmaceutical Society guidance on ethical professional decision making during the pandemic.

 

We also chatted about the Headspace app. You can access and download it here. If you are under pressure and feel that you need support at this time click here.

 

If you prefer to never miss an episode you can subscribe on your preferred podcast platform. Just click on the links below to get going.

 

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Son of pharmacy owner jailed for illegal supply of controlled drugs

 

Following an investigation by the Medicines & Healthcare products Regulatory Agency (MHRA) a man from north London has been sentenced to 6 years in prison at Croydon Crown Court.

 

David Ihenagwa, 40, of Edmonton, north London was convicted for offences of supplying class B and class C controlled drugs, using his mother’s east London pharmacy as a criminal enterprise. He pleaded guilty to 1 charge of supplying class B drugs and 4 charges of supplying class C drugs from September 2015 to April 2016.

 

MHRA officers seized 13,440 Codeine Phosphate tablets from an address in Stoke- on- Trent on 8 June 2016. These were traced back to the pharmacy where Ihenagwa worked. The MHRA discovered that Ihenagwa purchased the tablets from a licensed wholesale dealer in Surrey and operated the criminal enterprise from his mother’s pharmacy business in east London where he worked as company secretary.

 

MHRA investigations showed that Ihenagwa regularly purchased far larger quantities of controlled drugs than would normally be dispensed from a high street pharmacy. Further investigations revealed that Ihenagwa had sold medicines on at least 23 separate occasions to a criminal group. Typically, the drugs would be collected by the gang, by the van load, from the pharmacy where Ihenagwa worked and shipped around the country.

 

Ihenagwa was charged with supplying Codeine Phosphate, a class B drug and 4 charges of supplying Diazepam, Zopiclone, Lorazepam, and Tramadol, all class C drugs. All the drugs are prescription-only medicines. Proceedings to confiscate the proceeds of Ihenagwa’s criminal activity are now underway.

 

Mark Jackson, MHRA Head of Enforcement said:

 

“It is a serious criminal offence to sell controlled drugs which are also prescription-only medicines without a prescription.

 

“We work relentlessly with regulatory and law enforcement colleagues to identify and prosecute those involved.

 

“Those who sell medicines illegally are exploiting vulnerable people and have no regard for their health. Prescription-only medicines are potent and should only be taken under medical supervision.”