Government receives notification of more than 3,000 medicine supply issues under new scheme

Medicine manufacturers have notified the government of a “shocking” number of supply disruptions and discontinuations in the 18 months since a new portal was set up to report problems.

The reports, made via the discontinuations and shortages (DaSH) portal, were for a total of 1,700 shortages and 1,500 discontinuations of drugs up to March 2022.

The DaSH portal was put in place in October 2020, following the enactment of the Health Service Products (Provision and Disclosure of Information) Regulations in July 2018.

Under the regulations, manufacturers are required to provide information to the health and social care secretary about the purchase, supply, price and availability of medicinal products — including whether there are any shortages or discontinuations of the medicines.

According to a review of the legislation, published by the Department of Health and Social Care (DHSC) on 12 August 2022, DaSH was set up to “improve the process by which marketing authorisation holders of relevant products notify DHSC of potential shortages and discontinuations which may affect the supply of their medicines marketed in the UK”.

The review added: “Most supply issues do not have an impact on patients because mitigation measures are put in place by the department. More information, and more timely information, means that the department can put these timely measures in place to ensure that patients are not impacted or if that is not possible, to minimise the impact on patients.”

However, more than half of pharmacists responding to The Pharmaceutical Journal’s annual salary and job satisfaction survey in July 2022 said that medicine shortages have put patients at risk “in the past six months”.

In the same month, the Pharmaceutical Services Negotiating Committee (PSNC) said that many community pharmacies are facing “a critical situation trying to source medicines in [a] timely manner”.

Reena Barai, an independent community pharmacy contractor and National Pharmacy Association board member, said: “The actual numbers of products either discontinued or in short supply are shocking, yet for us as community pharmacists the numbers aren’t surprising.

“It’s testament to the diligence and commitment of pharmacy teams that no patients have come to severe harm from not being able to get their medication. 

“Yet we know that teams have spent disproportionate lengths of time ‘jumping through hoops’ to ensure their patients don’t go without medication or a suitable alternative at least. The time spent doing this draws our stretched teams away from other services we could and should be providing to support the pressures in primary care and the wider NHS,” she added.

“The current flux in the market around pricing of medications that are in short supply is causing a huge amount of distress to all contractors and something needs to change in the way the system reimburses pharmacies to compensate for this.

“It is simply not fair that pharmacy teams are having to dispense often at a loss, as the concession prices aren’t published in a timely manner or can’t keep up with the market price increases. It is adding to the ‘stress’ the sector is already facing and sadly buckling under too.”

In February 2022, the PSNC attributed a spike in price concessions to COVID-19-related staff absences, changes in trading post-Brexit and increases in oil prices.

Nat Mitchell, pharmacist and director at JWW Allison and Sons pharmacy in Cockermouth, Cumbria, said the issue of medicine shortages “is certainly a shocking one”.

“We are seeing shortages across the range of medications we use, from travel vaccines through to routine medication, which is either completely unavailable at any of our numerous wholesalers or only available at a huge price increase.

“Trying to source these medications is taking up an increasing amount of time and it’s how I often start my working day if I haven’t already looked at home before I leave for work. We are then having to contact surgeries to make them aware of shortages or reschedule appointments for vaccines, which is far from ideal,” he said.

Ross Maclagan, distribution and supply chain policy manager at the Association of the British Pharmaceutical Industry (ABPI), said: “The ABPI and many others provided feedback as the dashboard system was developed, to help ensure it worked for companies.

“We think it is an improvement on the old system of spreadsheets via email, which was not very user-friendly and could be much slower to coordinate actions.

“It’s important to be aware that notifications on the system can be made and then subsequently withdrawn, as the supply situation changes. We continue to work with the DHSC and members to make sure that information on medicine supply is as up to date as possible.”

The government’s legislation review also covered the Health Service Medicines (Price Control Penalties and Price Control Appeals Amendment) Regulations 2018, which came into effect on 11 April 2018, giving the DHSC powers to limit the prices of generic medicines and fine manufacturers that exceed those limits.

However, the review said: “While no price control determinations have been made there are still situations where the cost of a product has caused concern.

“For example, there may be instances when a product’s price considerably increases with no obvious justification. It therefore remains appropriate for the provision under section 262(1)(a) of the 2006 act to be retained by the Secretary of State, should this price limiting power be used going forward.”

In November 2020, The Pharmaceutical Journal revealed that drug tariff price increases for some generic medicines cost the NHS an additional £76m between July 2018 and October 2020.