Generic panic post-Brexit

Victoria Goldman investigates how the pharmaceutical industry, pharmacy bodies and pharmacies are preparing to ensure patients have access to medicines post-Brexit…

 

 

The UK faces political and economic uncertainty across all areas of society with Brexit looming. As far as community pharmacy is concerned, such uncertainty largely revolves around the issue of whether it will be able to get medicines to patients smoothly after the country leaves the European Union.

The pharmaceutical industry and pharmacy organisations are working closely with the Department of Health and Social Care (DHSC) to help manage the potential risks to medicines supply (branded and generics) as a result of the UK’s exit from the EU, particularly in the event of a no-deal scenario.

Yet many community pharmacists and local pharmaceutical committees are concerned about the impact Brexit will have on patients, communities and, of course, businesses. In particular, PSNC and others have been considering what measures might need to be in place in addition to the six-week stockpile that the government has asked the manufacturers of prescription medicines to hold in the UK.

One key message that’s getting across to healthcare professionals and patients is that it’s essential not to panic – ‘keep calm and carry on.’ For community and hospital pharmacies, patient care needs to remain the priority.

As PSNC chief executive Simon Dukes insists: “We will continue to work very closely with government and the DHSC on these contingency measures, with our objective being to minimise the impact of Brexit on the medicines supply chain, so that healthcare professionals can spend more time focusing on patient care, rather than sourcing medicines.”

 

Fluctuating market

Over the last year, the supply of generic medicines has fluctuated, causing shortages along the chain and impacting on pharmacies and patients.

Last month, Stuart Gale, chief pharmacist and owner of www.oxfordonlinepharmacy.co.uk (online dispensing arm of the Frost Pharmacy Group in Oxfordshire), said he had experienced some issues sourcing commonly prescribed generic medicines over the previous six to 12 months and this seemed to have intensified over the previous three months in particular.

Mandeep Mudhar, Numark’s director of marketing, agrees that this can be frustrating.

“The marketplace seems to have peaks and troughs on a consistent basis,” he says. “At present, the supply is very much the same as it’s been over the last year. There have certainly been sporadic shortages now and again, then price fluctuations, and then it takes a while for the supply chain to catch up.”

Warwick Smith, the director general of the British Generic Manufacturers Association (BGMA), says supply issues have partly been due to a problem with sourcing the active pharmaceutical ingredients.

“A lot of these are now sourced from India and China from large suppliers – this applies to brands as well as generic medicines – and there is nothing that can be done if there is a problem at the sourcing end of the chain,” he says. “There has also been an impact on quality concerns by either the manufacturer or regulator. The manufacturer may find a problem during batch testing and will typically destroy the product before putting the problem right and starting again.

“This can take a while to rectify, leading to short-term shortage issues. Regulators may also find an issue with quality concerns, although sometimes this is about the data storage rather than the product itself.

“This can have a longer term impact on the supply, although other companies then ramp up production to ensure the supply chain isn’t interrupted for too long.”

 

Brexit concerns

Smith says it’s important to distinguish between different Brexit scenarios.

“If an exit deal is agreed between the UK and EU, this will include a transition period before the end of 2020, so life will carry on pretty much the same as it already is,” he says.

“But if there’s no deal, there is likely to be a reduction in goods flow across the English Channel. Currently, Dover-Calais and Folkestone-Calais are important routes, with the majority of medicines/components coming in via Dover.

“We are looking into the disruption this could produce and taking mitigating measures. Companies are being asked to increase their inventory by six weeks’ additional supply. The government continues to review what could happen and we are having weekly discussions.”

Mike Thompson, the chief executive of the Association of the British Pharmaceutical Industry, says pharmaceutical companies will continue to do everything in their power to make sure patients can get access to medicines, whatever the Brexit scenario.

“This includes duplicating processes, changing supply routes and stockpiling medicines in line with the government’s guidance,” he says.

“Stockpiling more medicines is not the solution to this problem. However, we have been clear that there are things that are out of our control.”

For Mudhar, it is the fear of the unknown that remains the main issue.

“We have written to the government asking them to bring it to the table about whether the pharma companies should be holding more stock in the UK,” he says.

“It would help if the government gave an indication of the issues, but instead we are in a period of uncertainty. The PSNC is having conversations with the government, as we literally need clarity. The message to pharmacists is ‘don’t panic’ however.

“There is a robust supply chain in place and hundreds of suppliers are specialists in supplying generic medicines. If pharmacists and hospital pharmacies start holding extra stock, this would then cause problems in the supply chain and it’s not economical for them to do so either.”

Smith says that in the worst case scenario, the government needs to take charge. “If several bodies are taking action at the same time, this increases the chances of chaos and shortages, so it’s important that pharmacy organisations work together with the government,” he says.

“The security of the supply of medicines is top priority, and measures will be put in place to make sure patients receive the medicines they need.”

 

Maintaining patient need

Pharmacy bodies continue to advise pharmacists and patients not to stockpile medicines.

“Many people rely on medicines to help them to stay healthy or to manage existing health conditions,” Dukes says.

“Ensuring that UK patients can continue to access these medicines after Brexit must be a priority, whatever approach is taken to Brexit. Community pharmacists are experts in medicines and already spend a considerable amount of time sourcing medicines so their patients can access the medicines they need, when they need them.

“Recently, following a serious shortage of Epipens, this included putting in place a pharmacy protocol to prioritise access so that those patients most in need of the medicines received the limited supplies available.”

Gale says it would be irresponsible just to assume everything will continue uninterrupted, particularly with so many headlines warning that this will not be the case. But, he stresses, a pharmacist’s job is not to speculate.

“We are doing all we can to pre-empt any issues,” he says. “We will continue to manage the situation to the best of our ability with the information we have available.

“It is difficult for patients not to worry about the continuity of supply, not least because of the media coverage on the subject. The truth is that no one knows how things will play out.

“From a community pharmacy perspective, all we can do at this stage is reassure people that we will continue to do our best to ensure they receive the most appropriate treatment, seeking alternatives where necessary.”

However, not all pharmacies are taking on board the official ‘don’t stockpile’ advice. In October 2018, Robbie Toan, founding director of online Cheshire-based-pharmacy Assured Pharmacy, which specialises in men’s embarrassing health treatments, said that he was stockpiling medicines to avoid potential Brexit-related supply problems but this has taken its toll on cash flow.

“Our whole business is based on repeat prescriptions, so if people can’t get it from us they are going to go elsewhere and we’ve lost that patient forever,” he says.

“We’re stockpiling because we can’t risk running out. Holding £500,000 worth of stock for a business of our size is not the norm. In the pharmacy industry, you shouldn’t be holding anything more than a month or six weeks of stock and we now have about seven months of stock.

“We’ve had to expand our storage facilities for it too, which has cost us an extra £25,000 a year.”

 

Alternate strategies

In December 2018, the PSNC revealed that if actual shortages of branded medicines occur, the preferred option would be to allow pharmacies to generically substitute certain medicines.

Dukes says that, in addition to the six-week stockpile of prescription medicines, there will need to be some other measures in place.

“The introduction of a national ‘serious shortage protocol’ would give pharmacies more flexibility if serious shortages occur, and we support that measure,” he says.

“We would also like pharmacists to be allowed to use their knowledge of medicines and professional skills to substitute certain medicines for others in shortage situations.

“Generic substitution would see pharmacies dispensing generic equivalents in place of certain prescribed branded medicines that have been agreed at a national level, where those branded products are in short supply.

“This would reduce any issues caused by shortages for those medicines that can be easily substituted with an equivalent generic product. We believe that in addition to this stockpile, there will need to be processes in place to help community pharmacies and other healthcare providers to work together to manage any shortages that do occur.

“Community pharmacists and GPs in particular will need to work together with clear guidance on the steps to follow in the event of a drug shortage. There will also need to be flexibility in the regulatory, contractual and reimbursement structures.”

 

 

Picture: CharlieAJA (iStock)

 

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