News

Media And Political Bulletin – 16 March 2020

Media and Political Bulletin

16 March 2020

Media Summary

‘Unprecedented demand’ for OTC painkillers as COVID-19 outbreak spreads

The Pharmaceutical Journal, Debbie Andalo, 13 March 2020

The Pharmaceutical Journal reports that pharmaceutical wholesalers are not ruling out supply issues in the near future as demand for medicine rises amid the outbreak.

Martin Sawer told The Pharmaceutical Journal that while there are currently no medicines shortages in the UK, there could be issues “around the corner”.

“The demand level for medicines across the board from community pharmacists, doctors and patients has gone up dramatically compared to what it usually is this time of year,” he said. However, he added that “there are not supply shortages”. Sawer added that wholesalers were using drugs from the stockpiles created for Brexit, but added “there could be a manufacturing issue around the corner.”

The owner of LloydsPharmacy has said there is “unprecedented demand” for over-the-counter painkillers as a result of the COVID-19 pandemic. A statement released on 12 March 2020 from McKesson said it had put processes in place to “minimise” the impact of shortages of medicines and to continue to be able to provide a “consistent supply of critical products” from its stores.

Alliance Healthcare said it had faced similar pressures, while a spokesperson for Phoenix said it had seen a “considerable increase” in demand for medicines including paracetamol and Calpol.

Brexit threatens UK’s ability to respond to a future pandemic

The Guardian, Martin McKee, Anniek de Ruijter and Mark Flear, 14 March 2020

Martin McKee (professor of European public health at the London School of Hygiene and Tropical Medicine), Anniek de Ruijter (associate professor at Amsterdam Law School) and Mark Flear (reader in law at Queens University, Belfast) write in the Guardian that Brexit threatens the UK’s ability to respond to the novel coronavirus and future pandemics.

Media attention has already highlighted the damage that being outside the EMA will do to the British economy, however the consequences of being outside the EMA go much further. The UK now lies outside the EMA’s rapid authorisation mechanism for pandemic vaccines and medicines for treatment. Consequently, the UK could have to wait longer for these than EU member states.

In addition, they write, the UK has also withdrawn from the EU’s emergency bulk buying mechanism for vaccines and medicines, which allows EU member states to increase their market power and speed up access to vaccines and medicines during a crisis. Its exclusion could mean the UK will have to pay more to acquire these pandemic countermeasures.

This was reported on by The New European, the Independent, the Mirror and the Express.

Covid-19 presenting ‘increasing pressures’ on community pharmacies

ITV News, 14 March 2020

Cathy Harrison, Chief Pharmaceutical Officer at the Department of Health of Northern Ireland, told ITV News that the Covid-19 strain of Coronavirus is presenting ‘increasing pressures’ on community pharmacies.

Cathy Harrison says people needing medication should not stockpile and should continue to take their medication as normal, saying stockpiling could ‘disadvantage other patients’.

It comes as Northern Ireland saw its biggest spike in Coronavirus cases on Friday with 29 people diagnosed with the disease. Three cases came from community transmission.

Tackling COVID-19: EFPIA welcomes proactive and regular dialogue with Commissioners on the supply of medicines during the COVID-19 pandemic

EFPIA, 13 March 2020

Last week representatives from EFPIA joined a call with Health Commissioner Kyriakides, Commissioner Breton and Commissioner Lenarčič together with representatives from across the medicines and medical devices supply chain, to discuss the potential impact of the coronavirus on the supply of vaccines and medicines.

Speaking after the first of what will become weekly calls, EFPIA Director General Nathalie Moll said: “We welcome the proactive approach from the Commissioners and the opportunity for regular dialogue at this critical time. The biopharmaceutical industry in Europe remains fully committed to global efforts to care for those affected, contain the outbreak and develop resources to tackle future outbreaks.”

EFPIA reiterates that the continuity of supply of medicines to patients remains of the highest priority, and that members have comprehensive business continuity and contingency plans in place. Companies are constantly monitoring global and market-specific demands for their products and take all inventory decisions carefully because supply disruptions can affect patients globally.

EFPIA is in constant dialogue with its members and authorities.

Fluoxetine 10mg tablet SSP published

Dispensing Doctors’ Association, Ailsa Colquhoun, 13 March 2020

Dispensing Doctors’ Association reports that a Serious Shortage Protocol (SSP) has been issued for fluoxetine 10mg tablets. This enables community pharmacists in England, Wales and Northern Ireland to supply patients with fluoxetine 10mg capsules.

Dispensers faced with shortages of fluoxetine 10mg tablets should request that the GP alters the prescription to fluoxetine 10mg capsules to enable the supply. This SSP will run until Friday 12 June.

This was also reported in C+D.

Current list of products under export ban due to national shortages

C+D, Eliza Slawther, 13 March 2020

C+D reports that hydroxychloroquine has been added to the list of medicines and products that cannot be exported from the UK as of March 14.

An initial 23 products were listed on October 4 last year, with more added and removed since. All the products are at “high risk of parallel export”, due to their prices increasing in EU countries, the Department of Health and Social Care (DH) told C+D in October.

By restricting wholesalers from exporting these products, the DH hopes “to tackle ongoing shortages and minimise the impact on patients”, it also said.

The list will be updated with each product that the DH subjects to export restrictions, and applies to all medicines containing the active ingredients, whether generic or branded.

GPhC launches guidance on getting medicines online

Pharmacy Business, Kiran Paul, 13 March 2020

Pharmacy Business reports that the GPhC, along with other healthcare regulators, has launched a new guide to help people access safe and right medicines or treatment online. The guide has a six-point check list for anyone going online for medicines or treatment.

“Online healthcare services and apps can bring real benefits for people, but there can also be significant risks, particularly if you use online services which are not regulated in the UK,” commented Duncan Rudkin, chief executive of the GPhC.

“We hope this advice will be particularly helpful during the coronavirus outbreak, when more people may be considering going online for medicines and when some unregulated websites may be offering fake medicines or false information”.

 

 

Parliamentary Coverage

There was no parliamentary coverage today. 

 

Full Coverage

‘Unprecedented demand’ for OTC painkillers as COVID-19 outbreak spreads

The Pharmaceutical Journal, Debbie Andalo, 13 March 2020

Pharmaceutical wholesalers are not ruling out supply issues in the near future as demand for medicine rises amid the outbreak.

The owner of LloydsPharmacy has said there is “unprecedented demand” for over-the-counter painkillers as a result of the COVID-19 pandemic.

A statement released on 12 March 2020 from McKesson said it had put processes in place to “minimise” the impact of shortages of medicines and to continue to be able to provide a “consistent supply of critical products” from its stores.

The statement added: “We are doing everything we can to ensure we provide a consistent supply of medicines. This includes sourcing from multiple providers, and putting commitments in place with manufacturers to secure supply.”

Meanwhile, Martin Sawer, executive director of the Healthcare Distribution Association — the membership organisation for UK wholesalers — told The Pharmaceutical Journal that while there are currently no medicines shortages in the UK, there could be issues “around the corner”.

“The demand level for medicines across the board from community pharmacists, doctors and patients has gone up dramatically compared to what it usually is this time of year,” he said.

However, he added that “there are not supply shortages”.

“There may be cases where deliveries into pharmacies may not be the [entire] amount they ordered because they are ordering a lot more than they would normally, so they are not getting the whole delivery the first time.

“The situation is just like supermarkets — they’ve got enough food but people are taking things off the shelves. We’ve got enough medicines.”

Sawer added that wholesalers were using drugs from the stockpiles created for Brexit, but added: “I wouldn’t say I’m not worried [about the impact of COVID-19]. The situation with the coronavirus changes quite quickly and supplies can change quickly but usually that is down to a manufacturing problem which we didn’t know about.

“We are managing at the moment and I feel confident, but there could be a manufacturing issue around the corner.”

A spokesperson for Phoenix, one of the UK’s largest pharmaceutical wholesalers, said it had seen a “considerable increase” in demand for medicines including paracetamol and Calpol.

“We have put in place some order restrictions for certain products to ensure equitable supply across the UK, but again emphasise that customers should only purchase according to need,” they said.

“Prices for some medicines have increased, but this is beyond the control of medicine distributors like Phoenix”.

Similarly, Alliance Healthcare said it had faced similar pressures.

A spokesperson for the wholesaler said: “There has been a significant increase in the demand for products such as paracetamol and ibuprofen over the last few weeks, which has caused some supply constraints.”

Gordon Hockey, director of operations and support at the Pharmaceutical Services Negotiation Committee (PSNC), said the government had already “approached medicine suppliers to assess the impact that COVID-19 could have on the supply chain”.

“The PSNC is keeping a close eye on the generic medicines, including paracetamol, affected by recent price hikes and is making applications to the Department of Health and Social Care (DHSC) for price concessions in the usual way,” he said.

“The PSNC has also commenced discussions with the DHSC on protection for pharmacies against sudden price rises and launched the Community Pharmacy COVID-19 Forum, providing an opportunity for information sharing with other pharmacy and supply chain bodies, DHSC and NHS England and NHS Improvement.”

Brexit threatens UK’s ability to respond to a future pandemic

The Guardian, Martin McKee, Anniek de Ruijter and Mark Flear, 14 March 2020

Brexit threatens the UK’s ability to respond to the novel coronavirus and future pandemics.

The coronavirus pandemic could not have come at a worse time for the UK and its citizens. Just as UK government ministers are digging in for the really difficult part of Brexit, the negotiations on future relationships with the EU and the rest of the world, a new virus comes out of China that reminds us of just why international co-operation is so important.

The obvious response, one might think, would be to do everything to safeguard those areas where the UK does collaborate, so as to reduce the threat of infectious disease. Instead, the UK has decided to isolate itself from European systems that have been built up over the past decade, many as a result of problems exposed by the 2009 swine flu pandemic.

The UK’s decision to leave the European Medicines Agency (EMA), an arm of the European Commission, has been discussed at length. The EMA is responsible for overseeing clinical trials for new vaccines and medicines for pandemics, and deciding on marketing authorisations for them that apply across the EU. Media attention has highlighted the damage that being outside the EMA will do to the British economy – both through lost activity among UK researchers and suppliers, and by making the UK a less attractive place for major pharmaceutical companies.

However, the consequences of being outside the EMA go much further. The UK now lies outside the EMA’s rapid authorisation mechanism for pandemic vaccines and medicines for treatment. Consequently, the UK could have to wait longer for these than EU member states. To make matters worse, the UK has also withdrawn from the EU’s emergency bulk buying mechanism for vaccines and medicines, which allows EU member states to increase their market power and speed up access to vaccines and medicines during a crisis. Its exclusion could mean the UK will have to pay more to acquire these pandemic countermeasures.

The government could, if it wished, go for a much closer alignment with the EU, a choice made by Norway, Liechtenstein, and Iceland, which form the European Economic Area (EEA). These countries are on the same footing as regulators in EU countries. However, the difference is that these countries are in the single market and have accepted its rules. Even Switzerland, which is outside the EEA, has bespoke arrangements with the EMA based on its alignment to EU rules.

A deal similar to the Ukrainian Association Agreement with the EU is another option. But each of these non-member states is outside the EU’s bulk buying mechanism for vaccines and medicines. In any case, all of these models seem unacceptable to the current UK government.

There other ways that the UK could mitigate the problems that come with being outside the EMA. One would be to copy Singapore, which has decided to automatically recognise EMA marketing authorisations, as well as those issued by the US Food and Drug Administration, subject to a 60-day Verification Route. However, this would be contrary to the UK government’s refusal to be a “rule taker”.

Finally, the UK could also, at least in theory, create its own rapid marketing authorisation mechanism. The slight problem is that this would almost certainly be impossible in the short term, not least because of the need to attract skilled staff. Many staff would have to be recruited internationally, and they may well be put off by the UK’s harsh, and extremely expensive, immigration regime. And even if a new UK mechanism did work, it would not necessarily ensure swift access to medicines as UK standards may diverge from those in the EU, a real threat given the upcoming implementation of the recent EU clinical trials regulation.

Concerns about UK divergence have been exacerbated by health secretary Matt Hancock, commenting that the UK’s medicines regulator could reduce bureaucracy, which signifies an intention to diverge. Clinical trials data and marketing authorisations in the UK, especially when made on the basis of that data, may not satisfy the EMA. Some pharmaceutical companies may therefore opt to base clinical trials in the EU, or in third countries that apply EU-compliant standards, so as to ensure they obtain marketing approval through the EMA for the EU market.

Pharmaceutical companies with UK manufacturing plants, including AstraZeneca, have already established batch control sites and pharmacovigilance teams in EU member states. This is to ensure they can continue to lawfully supply medicines in the EU. Pharmaceutical companies, facing the very large administrative burden involved in obtaining marketing authorisation, are likely to prioritise the EU’s single market over the UK’s far smaller market, as already happens with Switzerland and Canada.

It is a Canada-style trade deal that the UK is now pursuing, although it has not ruled out what it describes as an Australia-style deal, which is in effect code for no deal. Yet this could take upwards of eight years to agree, and EU negotiators are likely to drive a hard bargain. As with any deal with the US, itself very unlikely, this will demand that the UK make choices about who to align with.

For all of these reasons, if, as seems likely, a vaccine is developed against the 2019-nCoV virus, the UK is likely to have to join the queue for access with other countries, and to pay more than it otherwise would as an EU member state.

So while, in one respect, the timing of the pandemic could not have been worse for the UK, in another it could provide an opportunity to reflect on whether an isolationist ideology really is such a good idea. It has taken many years to build up the EU’s systems of defences against infectious disease. In an ever more uncertain and interconnected world, is it really a good idea to withdraw from them?

Martin McKee is professor of European public health at the London School of Hygiene and Tropical Medicine; Anniek de Ruijter is associate professor at Amsterdam Law School; Mark Flear is reader in law at Queens University, Belfast.

This was reported on by The New European, the Independent, the Mirror and the Express.

Covid-19 presenting ‘increasing pressures’ on community pharmacies

ITV News, 14 March 2020

The Covid-19 strain of Coronavirus is presenting ‘increasing pressures’ on community pharmacies, according to the Chief Pharmaceutical Officer.

Cathy Harrison says people needing medication should not stockpile and should continue to take their medication as normal.

It comes as Northern Ireland saw its biggest spike in Coronavirus cases on Friday with 29 people diagnosed with the disease. Three cases came from community transmission.

There have been 90 confirmed cases in the Republic of Ireland.

Retail premises have saw items such as toilet rolls and hygiene products being cleared from shelves.

The Chief Pharmaceutical Officer says stockpiling could ‘disadvantage other patients’.

“People should order prescriptions and take their medicines as normal,” said Harrison.

“Covid-19 is presenting increasing challenges for the dedicated staff working in our community pharmacies,” she continued.

“The Department is working to ensure that everyone continues to have access to their local community pharmacy. It is vital at this busy time that we are mindful of the pressure that community pharmacy staff are under.

“There is no need for you to do anything new or different when ordering or taking your medicines.”

She continued: “People should order prescriptions and take their medicines as normal.

“Extra supplies should not be ordered from your doctor.

“Stockpiling or purchasing medication that you do not need is completely unnecessary and could disadvantage other patients.

“There are no prescription medicine shortages as a result of Covid-19.”

Tackling COVID-19: EFPIA welcomes proactive and regular dialogue with Commissioners on the supply of medicines during the COVID-19 pandemic

EFPIA, 13 March 2020

Earlier today representatives from EFPIA joined a call with Health Commissioner Kyriakides, Commissioner Breton and Commissioner Lenarčič together with representatives from across the medicines and medical devices supply chain, to discuss the potential impact of the coronavirus on the supply of vaccines and medicines.

Speaking after the first of what will become weekly calls, EFPIA Director General Nathalie Moll said: “We welcome the proactive approach from the Commissioners and the opportunity for regular dialogue at this critical time. The biopharmaceutical industry in Europe remains fully committed to global efforts to care for those affected, contain the outbreak and develop resources to tackle future outbreaks; through research into vaccines, diagnostics and treatments for COVID-19, through donations and in-kind support on the ground and by working to ensure the continued supply of medicines and vaccines.”

The continuity of supply of our medicines to patients has been, and remains, of the highest priority. EFPIA members have comprehensive business continuity and contingency plans in place. Companies are constantly monitoring global and market-specific demands for their products and take all inventory decisions carefully because supply disruptions can affect patients globally.

EFPIA is in constant dialogue with its members and authorities. From the latest information received, there is limited immediate risk that COVID-19 would impact manufacturing and supply of branded medicines in Europe in the short term. While supply and demand vary by product, EFPIA members are not aware of any significant near-term impacts on the availability of our medicines and vaccines. Companies have also assessed potential longer-term impacts. The situation is fluid, but at this point EFPIA members do not anticipate impacts to their supply chains unless disruption due to the COVID-19 outbreak is sustained over the next several months. We continue to monitor the situation closely and we will keep an open and constant dialogue with the European Medicines Agency and the European and National Authorities as important information becomes available.

The uncertainty with respect to the length and extent of the pandemic poses a challenge for everyone involved in the fight against COVID-19. We support the Commission in its goals to minimize any impacts to the quality of care for patients in Europe, including access to medicines and vaccines. We look forward to continuing to work in partnership with the Commission and EMA, the Member States, their Competent Authorities and our supply chain colleagues to address challenges as they arise with pragmatic approaches that put patient needs first. At the same time, researchers from across our member companies will continue the quest to find diagnostics, vaccines and treatments to address the crisis.

Fluoxetine 10mg tablet SSP published

Dispensing Doctors’ Association, Ailsa Colquhoun, 13 March 2020

A Serious Shortage Protocol (SSP) has been issued for fluoxetine 10mg tablets. This enables community pharmacists in England, Wales and Northern Ireland to supply patients with fluoxetine 10mg capsules.

Dispensers faced with shortages of fluoxetine 10mg tablets should request that the GP alters the prescription to fluoxetine 10mg capsules to enable the supply.

This SSP will run until Friday 12 June. For more information, visit the NHS Business Services Authority (BSA) website.

This was also reported in C+D.

Current list of products under export ban due to national shortages

C+D, Eliza Slawther, 13 March 2020

Hydroxychloroquine has been added to the list of medicines and products that cannot be exported from the UK as of March 14.

An initial 23 products were listed on October 4 last year, with more added and removed since.

All the products are at “high risk of parallel export”, due to their prices increasing in EU countries, the Department of Health and Social Care (DH) told C+D in October.

By restricting wholesalers from exporting these products, the DH hopes “to tackle ongoing shortages and minimise the impact on patients”, it also said.

The list will be updated with each product that the DH subjects to export restrictions, and applies to all medicines containing the active ingredients, whether generic or branded.

GPhC launches guidance on getting medicines online

Pharmacy Business, Kiran Paul, 13 March 2020

The General Pharmaceutical Council (GPhC), along with other healthcare regulators, today launched a new guide to help people access safe and right medicines or treatment online.

The guide has a six-point check list for anyone going online for medicines or treatment:

  1. Check if the online healthcare service and healthcare professionals working there are registered with UK regulators.
  2. Ask questions about how the service works
  3. Answer questions honestly about your health and medical history
  4. Find out your options for treatment and how to take any medicines you’re prescribed
  5. Expect to be asked for consent for information to be shared with other healthcare professionals involved in your care
  6. Check what after-care you will receive

“Online healthcare services and apps can bring real benefits for people, but there can also be significant risks, particularly if you use online services which are not regulated in the UK,” commented Duncan Rudkin, chief executive of the GPhC.

“We hope this advice will be particularly helpful during the coronavirus outbreak, when more people may be considering going online for medicines and when some unregulated websites may be offering fake medicines or false information”.

The guide also offers supporting information such as methods to check the regulatory status of the services and professionals.

In addition to the GPhC, the online guide is supported by Care Quality Commission, Healthcare Improvement Scotland, Healthcare Inspectorate Wales, General Medical Council, Medicines and Healthcare Products Regulatory Agency, Nursing and Midwifery Council, Pharmaceutical Society of Northern Ireland, Pharmacy Forum NI and the Royal Pharmaceutical Society.

Sandra Gidley, president of the RPS, said: “It is important to recognise there are benefits and risks to buying medicines online. Keeping patients safe is essential as there are many unregulated sites out there which look legitimate.

“The guidance builds on recommendations from across healthcare that will help people to avoid illegal sites and help protect patients from fake medicine or obtaining prescription-only medicines without a prescription.”

Media And Political Bulletin – 16 March 2020

From Factory to Pharmacy

As part of our mission to build awareness, understanding and appreciation of the vital importance of the healthcare distribution sector, we developed an infographic explaining the availability of medicines. It identifies the factors that can impact drug supply, as well as the measures that HDA members undertake day in, day out to help mitigate the risks of patients not receiving their medicines.

See the Infographic

Apply to become a Member

Membership of the HDA guarantees your organisation:

  • Access to leading policy and industry forums of debate and discussion
  • Invitations to a range of networking industry events organised through the year, including an Annual Conference and a Business Day
  • Representation on HDA working parties, including the Members’ Liaison Group
  • A daily Political and Media Bulletin and HDA Newsletters
  • Access to HDA policy documents and all sections of the HDA website
  • Branding and marketing opportunities
Apply Now

Already a Member?