Pharmacy bodies have spoken out against an increasing number of medicine recalls and notifications that pharmacy teams are having to deal with.

This included the Association of Independent Multiple Pharmacies (AIMp), which has called for an inquiry into the cause of the issue.

The number of medicine recalls and patient safety alerts have increased in recent years, data on the Medicines and Healthcare Products Regulatory Agency (MHRA) website, analysed by The Pharmacist, has shown.

MHRA figures suggest an average of 55-60 medicine recalls or notifications issued each year since 2019, compared to an average of 20-30 between 2015 and 2019.

These figures include a range of notifications – from notices about incorrect patient information leaflets to recalls for medicines defects and risk of patient harm – and may be relevant to both hospital and community pharmacy.

But Community Pharmacy England (formerly known as PSNC) told The Pharmacist that their own records of notices that required community pharmacy action also showed an increase.

And AIMp and the National Pharmacy Association (NPA) said that their members had noticed an increase in the number of medicines alerts that they had to respond to, noting the pressure this put on already overstretched pharmacy teams.

The MHRA said that there had been an increase in packaging and labelling errors that often give rise to a Class 4 Alert, which suggests ‘caution in use’. But it said there was ‘no established reason’ for the increase.

It added that patient safety was its top concern, and that increased vigilance may have led to a rise in reporting and communication of errors.

AIMp calls for inquiry into causes of increasing recalls

Dr Leyla Hannbeck, chief executive officer of AIMp described product recalls as ‘an increasing source of pressure and frustration for contractors’, especially ‘at a time when pharmacy is facing unprecedented challenges not only in funding but bureaucratic burdens’.

And she called for an inquiry to understand the cause of the issue.

‘There has been a noticeable escalation in the frequency of medicines recalls and AIMp believes that it is time for an inquiry into the root causes of these increasing numbers,’ she said.

‘We must ascertain if there are any trends to explain these increasing needs for recall of medicines. The pharmacy sector as the end user within the supply chain should be included in any review.’

Recalls unfunded but vital to patient safety

Alastair Buxton, director of NHS Services at Community Pharmacy England, said that medicine recalls were ‘a vital tool to protect patients’, and that ‘whilst a rise in the number of medicines subject to recalls is concerning, it is positive to see that the MHRA is doing its job by working to minimise any risks to patient safety’.

He said that handling recalls was ‘important but ultimately unfunded work’ undertaken by community pharmacists.

‘More recalls mean additional workload being placed on already overstretched pharmacy teams needing to identify affected stock to return to suppliers and dealing with queries from patients who received affected medicines,’ he said.

But he added that patient safety was a role that community pharmacists take very seriously. ‘Patient safety is, and will remain, a central concern for medicines supply, and our members will continue to do everything they can to keep their patients from harm,’ he said.

Manufacturers should review quality assurance processes

Jasmine Shah, head of advice and support services at the NPA, said that the organisation had also noticed an increase in the volume of alerts.

‘The amount of work involved for pharmacies for recalls can be considerable, depending on the alert level,’ she said.

‘In some cases, pharmacies need to identify all patients prescribed with the medicine, contact them, explain the recall and recommend alternative treatments, as well as log the actions taken.’

In the last few months, all pholcodine-containing products have been recalled from the UK due to a risk of anaphylaxis and Emerade pens have been recalled due to risk of device failure if dropped.

In addition, pharmacists were instructed to stop supplying affected batches of Levothyroxine due to a lower than required assay result, and a batch of Sildenafil 10mg/ml Oral Suspension was recalled as the press-in bottle adaptor supplied with the pack was too wide to fit the neck of the medicine bottle.

Ms Shah added that manufacturers should review their quality assurance processes ‘so that the problem is tackled at source, before releasing medicines into the medicines supply system’.

Manufacturers increasingly keen to be transparent about risks

Teresa Hitchcock, head of safety, health and environment for the UK at law firm DLA Piper, said that the increase in the number of recalls and product safety notices being issued could be due to an increased focus on governance within the industry, with manufacturers wanting to ensure they were transparent about potential risks.

She said that medicines and medical devices had the potential for an immediate, high risk of harm if they were found to be faulty, and so manufacturers forced to make a quick decision may choose to issue a recall in the first instance, before investigating the issue more thoroughly.

And she said that an increase in regulations that manufacturers had to comply with also made it more likely that they would issue a recall.

Meanwhile, a spokesperson for the Association of the British Pharmaceutical Industry (ABPI) told The Pharmacist that while ABPI members had not noticed any significant upturn in recalls, ‘companies take safety very seriously and if there is any issue with a product, they take immediate action’.

Could the pandemic have affected manufacturing processes?

Ms Hitchcock also suggested that it would be worth considering whether the pressures of the Covid-19 pandemic could have impacted on manufacturers’ ability to follow maintenance procedures within their factories, which may potentially also account for an increase in quality issues experienced during this period.

Increase in labelling errors, but ‘no established reason’, says MHRA

The MHRA said that patient safety was its top priority, and that pharmacovigilance and drug safety monitoring had improved over the last 10 years, as had the sharing of information by regulators.

‘Improved vigilance may result in more reports being made and seen,’ a spokesperson added.

It also confirmed that there has been an increase in packaging and labelling errors that often give rise to a Class 4 Alert – where there is ‘no threat to patients or no serious defect likely to impair product use or efficacy’.

‘As the medicine in these instances is of a good quality, it is not recalled, but replacement leaflets or warnings could solve any problems. Overall, there is no established reason for the increase,’ the spokesperson said.