News

Media And Political Bulletin – 10 March 2020

Media and Political Bulletin

10 March 2020

Media Summary

No respite in challenges for the generics sector

P3 Pharmacy, 28 February 2020

The HDA’s educational infographicFrom factory to pharmacy, was featured in P3 Pharmacy’s article reporting on the independent report by economics consultancy Oxera, commissioned by the BGMA, that highlighted the sector’s capacity to provide sustained and significant savings to the NHS and create greater patient access.

The infographic aims to explain some of the issues behind issues of drug availability and provide helpful information to those involved in dispensing and delivering vital medicines to UK patients.

Communications from SecurMed UK – FMD safety features, 06 March 2020

SecurMed UK has published two communications about:

  • Product not found Alert – Change in procedure
  • Password renewal

These communications can be viewed here.

Community Pharmacy COVID-19 Forum – NHS England preparedness letter, 09 March 2020

Yesterday afternoon, Keith Ridge sent a preparedness letter on COVID 19 to pharmacy colleagues:

See https://www.england.nhs.uk/coronavirus/primary-care/

and https://www.england.nhs.uk/coronavirus/wp-content/uploads/sites/52/2020/03/preparedness-letter-primary-care-pharmacy-9-march.pdf.

The letter is similar to Dr Nikita Kanani’s letter of 5 March but includes advice specifically for pharmacies.

PSNC has issued an update to pharmacy on the letter and other related developments, and added a news story to their website – see https://psnc.org.uk/.

Coronavirus: stockpiling medicine is unnecessary and may cause its own problems, experts warn

iNews, Ruchira Sharma, 09 March 2020

iNews reports that experts have warned that people should not stockpile medicines as there are no shortages due to Covid-19. Overprescribing or ordering more prescriptions than is necessary could create a problem for others, and goes against the advice issued by the government.

“Patients can be assured that everyone in the supply chain will continue to work together to do all that they can to ensure that they get the medicines they need,” said a spokesperson for the PSNC.

Some pharmacies confirmed that they are seeing an increase in the number of conversations with patients worried about the Covid-19 coronavirus.

But the Government confirmed there was little evidence to suggest supply chains in the UK were affected, the Royal Pharmaceutical Society said. Moreover, the country is prepared thanks to its precautions for a no-deal Brexit, explained Sandra Gidley, president of the RPS.

GPhC could suspend inspections due to coronavirus outbreak

C+D, Valeria Fiore, 09 March 2020

While GPhC inspections will continue as planned for the time being, suspending them could be a “potential option” depending on how the virus develops in the future, the regulator told C+D last week.

The regulator is liaising “with governments, the NHS and other organisations and is preparing appropriately for potential options and scenarios, including in relation to pharmacy inspections”, GPhC CEO Duncan Rudkin explained.

“Our priority is making sure patients and the public continue to receive safe services from pharmacies and pharmacy professionals. We also have an important responsibility to protect the health, safety and wellbeing of our staff and everyone affected by our work,” he said.

Europol notes ‘worrying trend’ in fake medicines

Life Sciences Intellectual Property Review, Rory O’Neill, 09 March 2020

Life Sciences Intellectual Property Review reports that EU authorities seized €7.9 million worth of counterfeit medicines – including fake cancer drugs, antivirals, and erectile dysfunction medicines – as part of an operation carried out last year. According to Europol, nearly 36 million units of counterfeit medicines were seized, accompanying 165 arrests in 12 European countries.

The operation was led principally by the French National Gendarmerie and Finnish customs, and run in conjunction with Europol, the European Union Intellectual Property Office and other national law enforcement agencies. Europol said the operation resulted in the interception of 12 criminal groups, and the recovery of €1.5 million worth of assets.

The drugs were trafficked through both online and offline channels.

 

 

Parliamentary Coverage

House of Commons – Written Answer, 09 March 2020

Ms Harriet Harman (Camberwell and Peckham): To ask the Secretary of State for Health and Social Care, what steps he is taking to ensure that women in Camberwell and Peckham constituency have adequate access to Hormone Replacement Therapy (HRT); and if he make an assessment of the adequacy of the medicine supply chain in relation to HRT.

Jo Churchill (answered on 09 March 2020): We are aware of ongoing supply issues with some hormone replacement therapy (HRT) preparations for a variety of reasons.

The National Health Service receives updates on the supply situation and availability of HRT products, and we are continuing to engage with organisations such as the Royal College of Obstetricians and Gynaecologists, the Faculty of Sexual and Reproductive Healthcare and the British Menopausal Society.

We have been working closely with all suppliers to resolve the issues as quickly as possible and maintain overall supply to patients across the United Kingdom, including those living in Camberwell and Peckham. Although some HRT products are still affected by supply issues, alternatives remain available, and the overall supply situation has been improving since February 2020 and will continue to improve over the coming months.

 

Full Coverage

No respite in challenges for the generics sector

P3 Pharmacy, 28 February 2020

A recent independent report by economics consultancy Oxera, commissioned by the British Generic Manufacturers Association (BGMA), has highlighted the sector’s capacity to provide sustained and significant savings to the NHS and create greater patient access. However, will the lack of certainty over the supply of medicines post-Brexit, while the government tries to sort out a longer-term arrangement with the EU, damage the sector and what do those in the know think is in store for the sector this year?

BGMA director general Warwick Smith says these “life-saving, life-enhancing” products need to be “a priority focus” when it comes to UK and EU discussions. “The more the UK’s regulatory regime for medicines diverges from the EU’s, the less likely it is that we can continue to supply the same range of products at the same price, which means there could be fewer new products available,” he says.

This is down to the way the industry operates. New products are launched first in the US and the EU because these are the biggest markets, so it’s economically advantageous for the company that’s putting them out. If we end up with a different regulatory framework in the UK, our products will be brought to market more slowly, which means more expense.

Supply and demand

“The Oxera report found the UK was still an attractive market in Europe because of its low barriers to entry,” says Mr Smith. “But if you need to do more to get through those barriers, it will be less attractive, which means new products will either come at a higher price or they won’t come at all.”

The BGMA has asked Matt Hancock, Secretary of State for Health and Social Care, to urge his colleagues to prioritise medicines supply on their Brexit to-do list. Mr Smith says that Mr Hancock has been very supportive, but nonetheless adds a note of caution. “There is of course a risk in any sort of negotiation that, with dozens of issues on the table, they get linked by negotiators who all want something,” says Mr Smith. “One hopes they all understand the importance for both sides of maintaining a free flow of medicines.”

Mr Smith says the current supply situation is “not far from the mid-range of normal, so although it’s not as good as we’d want it to be, it’s not as bad as we’ve seen it or as good as it has been in the past”.

What we are experiencing – and what seems always to make the news – is a small number of important products such as HRT facing sustained supply issues.

Mr Smith says it’s always difficult to pin down the exact cause in many cases. “We do still have concerns about active pharmaceutical ingredients plants in China being moved from urban centres to more rural areas in order to meet their new environmental criteria, but the Chinese government closed the old plants before opening up a new one, so things have not transitioned as smoothly as they might have.”

The implementation of the EU serialisation rules against falsified medicines has also had an impact on production costs, complexity and capacity. “Manufacturing capacity in Europe is quite tight, due in significant part to FMD, as printing the unique code on each pack reduces production capacity by about 10 per cent, which delays pack runs down the line,” says Mr Smith. “Plus, more strategically, we have seen the supply chain getting thinner and longer. If you face downward pressure on price, you tend to go for lower priced suppliers, so as a result of payors in Europe wanting to pay less for their generics, manufacturers are sourcing more of their needs from further afield, which makes the supply chain longer. This means that if something goes wrong, it takes longer and is harder to put right.”

Misconceptions on pricing

As long as the payors know this, then price fluctuations can be explained, but they have to spread the word down the chain in order to avoid misinformation about pricing snowballing into misconceptions about reimbursement.

“The Oxera report showed that most comparisons done with price look at the reimbursement price, which is very far off the manufacturer’s actual price,” says Mr Smith. “By comparing manufacturers’ actual sale prices, it showed we are the lowest in Europe, which is something we knew, but it’s useful to have an independent report confirming it.”

However, Mr Smith admits that there have been a small number of high-priced products that have caused concern. “In some of these cases, it was necessary to keep getting the product to the patient, but if a company is putting up prices for no good reason then they should be held to account and government should be able to investigate,” he says.

“We all need to understand how the supply chain has changed as result of downward pressure on price, and have a more strategic look at that. For example, we are getting to a stage where more originator products coming off patent are increasingly complex than we’ve seen in the past, so that will put pressure on the traditional generics model as it costs more to develop the products in the first place, which could call into question their sustainability in the long term because of the added complexity for manufacturers and higher costs for payors.

“At the other end of the scale, the sector is doing a lot of work on repurposing medicines where, for a comparatively small investment, we can add a new indication to an old molecule. However, the challenge here is that if one generic company does it, all the others can then market the product for the same new indications, although there are a number of business models that you could use to make this work. For example, the NHS could pay a generics manufacturer to do the work and then recoup that cost as the competition kicked in. It would mean joint working between the generic industry and the NHS in a way that has not been normal thus far, but we are in discussions about how to make it work.”

Comments echoed by manufacturers

Unsurprisingly, manufacturers echo these concerns about future challenges. “Drugs and their development have become more complex and expensive to meet the rising challenge of emerging disease areas,” says Peter Kelly, managing director of Accord Healthcare. “Too much downward pressure on price or a reduction in incentives for dispensers to make margins on generics is likely to reduce competition and therefore suppliers in the market, so it is important that we create a sustainable model for the whole industry where we focus on value and not just pricing. Unless manufacturers are able to see a level of sustainability in the core current generic medicine market, we may see less interest among manufacturers to come to the UK.”

Kim Innes, general manager of Teva UK & Ireland, says that while it’s clear that, overall, the generics sector delivers good value for the country, “margins are tight for the industry”. She says Teva’s strategy is to continue to leverage its portfolio to provide added value for customers, “whether that’s through our e-commerce generics portal or the numerous support programmes we offer for pharmacists. We’re also entering the world of complex generics, which is really exciting for us and creates access to better treatments for patients.”

Luke Hart, managing director of Creo Pharmaceuticals, which was bought by Zentiva in 2019, says: “The generics sector looks bright and, with regard to the UK, we anticipate there will continue to be a healthy level of competition. Recent investments in both in-house and third-party products support our aspirations of a strong growth trajectory. We have a significant launch programme planned in 2020 and beyond for pharmacy-dispensed products, but also within the hospital and speciality sector.”

The importance of safety

Given community pharmacy’s increasing focus on efficiency, but not at the expense of safety, many manufacturers are changing their approach to packaging control in order to differentiate strengths and molecules.

Zentiva has worked closely with the MHRA Patient Information Quality Unit to develop company-specific labelling and packaging solutions to address the issue of molecule and strength differentiation. Its colour schemes take into account pharmacy dispensary storage processes – acknowledging that different pharmacies may stock products alphabetically or by therapy area. Mr Hart says he would welcome patient and dispenser feedback on the new pack designs.

Accord Healthcare has also updated its packaging with new designs, colours and content layouts. “With a growing portfolio of more than 1,000 SKUs, it is difficult to make packs look different from one another using colour alone, so differentiating through different liveries minimises the chances of having lookalikes and signals that no design or colour scheme is specifically associated with any particular product range,” says Mr Kelly. “This encourages healthcare professionals and patients to carefully read product packaging.”

Reassurance on shortages

Patients trust pharmacies to supply them with the correct medicines, but when a product has issues with supply, it can be hard for the pharmacist to explain why. “We have some 20,000 products in the UK with complex supply chains, so every now and again, it’s to be expected that something will go wrong,” says Mr Smith. “It’s frustrating for patients when they are told that this is because of ‘manufacturing issues’. This can sound very vague.”

“More often than not,” he continues, “this is not the pharmacist’s fault, as they haven’t been told the reason themselves. So if, say, they could tell the patient it was because a manufacturer has found a quality issue and has had to recall a batch, I think the patient would probably think the inconvenience made sense. There are, however, some barriers to sorting this out because companies are not keen on telling their competitors what their specific supply problem is. This makes the communications chain to the pharmacist tricky, but it’s something I’m focusing on this year because it’s a service we should be trying to provide for pharmacists and patients.

Mr Smith makes an additional point: “I would also like to stress that so often we hear medicines supply issues all lumped under the label of ‘generic shortages’ when, in fact, of the 78 products on a recent NHS shortages bulletin, only 20 or so were made by generics companies and fewer than 10 were traditional unbranded generics, so this is not all a generics problem,” he says.

Mr Hart agrees. “Every shortage has a story and this needs to be understood,” he says. Ms Innes adds: “As an industry, we can’t forget the real anxiety a shortage can cause patients, and we have to be open with them and explain why medicines go out of stock and the broader challenges the industry faces. At the end of the day, while external factors obviously influence us and the market, what’s most important is understanding the needs of our customers and continuously working on building a close relationship with them. I think if you get that right, then the rest will follow.”

From factory to pharmacy

The Healthcare Distributors Association (HDA UK) has developed an educational infographic that aims to explain some of the issues behind issues of drug availability and provide helpful information to those involved in dispensing and delivering vital medicines to UK patients.

Communications from SecurMed UK – FMD safety features, 06 March 2020

SecurMed UK has published two communications about:

  • Product not found Alert – Change in procedure
  • Password renewal

These communications can be viewed here.

Community Pharmacy COVID-19 Forum – NHS England preparedness letter, 09 March 2020

Yesterday afternoon, Keith Ridge sent a preparedness letter on COVID 19 to pharmacy colleagues:

See https://www.england.nhs.uk/coronavirus/primary-care/

and https://www.england.nhs.uk/coronavirus/wp-content/uploads/sites/52/2020/03/preparedness-letter-primary-care-pharmacy-9-march.pdf.

The letter is similar to Dr Nikita Kanani’s letter of 5 March, a few days ago, but includes advice specifically for pharmacies, including advice on:

  • Relating to guidance from the GPhC to support pharmacists in these challenging times – that guidance includes: We recognise that in highly challenging circumstances, professionals may need to depart from established procedures in order to care for patients and people using health and social care services. Our regulatory standards are designed to be flexible and to provide a framework for decision-making in a wide range of situations. They support professionals by highlighting the key principles which should be followed, including the need to work cooperatively with colleagues to keep people safe, to practise in line with the best available evidence, to recognise and work within the limits of their competence, and to have appropriate indemnity arrangements relevant to their practice.
  • Encouraging pharmacies to check their business continuity plans ensuring collaboration with other pharmacies, practices and the wider healthcare community
  • Online bookings systems may need to be changed to ensure potentially infected patients understand they should not attend the pharmacy
  • No stockpiling of medicines by pharmacies – In general, excess purchasing or stockpiling of medicines can impact adversely on the supply chain and can result in shortages. It remains important therefore for pharmacies not to do this
  • Noting that GPs have been encouraged to use electronic repeat dispensing
  • Cancellation of the national clinical audit for this year (2019/20)

PSNC has issued an update to pharmacy on the letter and other related developments, and has added a news story to their website – see https://psnc.org.uk/.

The first forum meeting is this Thursday this week 10 – 11.30am.

Coronavirus: stockpiling medicine is unnecessary and may cause its own problems, experts warn

iNews, Ruchira Sharma, 09 March 2020

People should not stockpile medicines as there are no shortages because of Covid-19, experts have warned.

Overprescribing or ordering more prescriptions than is necessary could create a problem for others, and goes against the advice issued by the government.

“Patients can be assured that everyone in the supply chain will continue to work together to do all that they can to ensure that they get the medicines they need,” said a spokesperson for Pharmaceutical Services Negotiating Committee (PSNC), a body that promotes and supports the interests of all NHS community pharmacies in England.

Some pharmacies confirmed that they are seeing an increase in the number of conversations with patients worried about the Covid-19 coronavirus.

There are more than 110,000 cases around the world and at least 273 in the UK, according to the latest information from the Department Health and Social Care. Both figures are expected to rise.

Government prepared

In the wake of the outbreak, many of the world’s biggest drug makers in China and India have either shut or cut experts, resulting in global anxiety over supplies.

This is not an issue in the UK however, as the Government confirmed there was little evidence to suggest supply chains in the UK were affected, the Royal Pharmaceutical Society said.

Moreover, the country is prepared thanks to its precautions for a no-deal Brexit, explained Sandra Gidley, president of the Royal Pharmaceutical Society.

Patients particularly anxious over coronavirus have been advised to speak to their local pharmacists.

“As far as individuals are concerned, buying extra medicines when they are not needed is never a good idea as it can contribute towards potential shortages,” said Ms Gidley.

“Talk to your pharmacist if you have any concerns about your medicines. They already manage various medicines shortages on a daily basis and work hard to get patients the medicines they need to keep them well.”

The DHSC has asked suppliers who still retain some of their EU exit stockpiles to hold onto them in light of the Covid-19 outbreak.

“The Department of Health and Social Care has well-established procedures to deal with medicine shortages and has already approached medicine suppliers to assess the impact that Covid-19 could have on the supply chain,” said a PSNC spokesperson.

The DHSC has asked suppliers who still retain some of their EU exit stockpiles to hold onto them in light of the Covid-19 outbreak.

“There are many details still to be worked out and PSNC will be a part of those discussions, looking at how we can best protect the network of community pharmacies and allow them to continue their crucial work through this crisis,” explained Simon Dukes, PSNC chief executive.

Concerns for pharmacists

Front-line pharmacists are at great risk and must be considered when planning for the Covid-19 outbreak however, experts warned.

“Community pharmacy teams are already putting themselves at risk dealing with this illness, and that will continue to be the case as this situation worsens.

“Pharmacies must be treated as a core part of the NHS in all epidemic planning, and PSNC will ensure that HM Government is aware of the critical part they have to play and the support – including financial – they will need through any epidemic.”

GPhC could suspend inspections due to coronavirus outbreak

C+D, Valeria Fiore, 09 March 2020

The General Pharmaceutical Council (GPhC) could stop inspections if the coronavirus outbreak worsens, it has told C+D.

While GPhC inspections will continue as planned for the time being, suspending them could be a “potential option” depending on how the virus develops in the future, the regulator told C+D last week (March 6).

GPhC CEO Duncan Rudkin added that the regulator is “keeping the situation relating to coronavirus under active review”.

“Safe services”

The regulator is liaising “with governments, the NHS and other organisations and is preparing appropriately for potential options and scenarios, including in relation to pharmacy inspections”, Mr Rudkin explained.

“Our priority is making sure patients and the public continue to receive safe services from pharmacies and pharmacy professionals. We also have an important responsibility to protect the health, safety and wellbeing of our staff and everyone affected by our work,” he said.

Mr Rudkin added that the GPhC “will provide further updates about any action we decide to take in response to the developing situation if and when needed”.

The GPhC said last week it will take coronavirus into account if it receives concerns related to professionals on its register where the virus is a factor.

Meanwhile, NHS England has asked pharmacies to appoint a coronavirus lead and identify a space in the pharmacy where patients suspected to have the virus can be isolated.

As of today (March 9), 319 people had tested positive for coronavirus in the UK. England’s chief medical officer Chris Witty confirmed this afternoon (March 9) that a fourth patient had died due to the virus.

Europol notes ‘worrying trend’ in fake medicines

Life Sciences Intellectual Property Review, Rory O’Neill, 09 March 2020

EU authorities seized €7.9 million ($8.9 million) worth of counterfeit medicines—including fake cancer drugs, antivirals, and erectile dysfunction medicines—as part of an operation carried out last year.

According to Europol, which made the announcement on Friday, March 6, nearly 36 million units of counterfeit medicines were seized, accompanying 165 arrests in 12 European countries.

The operation was led principally by the French National Gendarmerie and Finnish customs, and run in conjunction with Europol (or the European Union Agency for Law Enforcement Cooperation), the European Union Intellectual Property Office and other national law enforcement agencies.

Europol said the operation resulted in the interception of 12 criminal groups, and the recovery of €1.5 million worth of assets.

Also among the counterfeit drugs were pseudoephedrine, antihistamines, anxiolytics, hormone and metabolic regulators, narcotics, painkillers, antiestrogens, hypnotics, and doping substances.

The drugs were trafficked through both online and offline channels.

The seizures indicate a “worrying trend” of trafficked counterfeit medicines entering the EU market, the Europol statement said. Such goods are made and packaged in underground labs, often in the EU, the agency added.

The 165 arrests were made in Belgium, Cyprus, Finland, France, Greece, Hungary, Italy, Portugal, Slovakia, Spain, Ukraine, and the UK.

Pfizer UK ran a social media campaign last year urging people not to be “catfished” by counterfeit drugs.

Neville Broad, manager of the counterfeit lab at Pfizer’s facility in Sandwich, Kent, said his team has found dangerous chemicals such as lead paint, brick dust, floor polish, and boric acid in counterfeit drugs.

“In the worst case they can kill you, in the best case they just won’t work,” Broad said.

The Intellectual Property Office of the Philippines said last year that fake medicines account for a quarter of all counterfeits seized by the country’s officials.

Media And Political Bulletin – 10 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

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