Drug shortages not causing patients harm, says Minister

Shortages of prescription medicines can cause inconvenience and distress to NHS patients, but the government is not aware of any examples of people suffering actual harm, Health Minister Earl Howe has said.

Nor does the government believe that parallel exporting is the main reason for drug shortages in the UK, the Minister told the parliamentary All-Party Pharmacy Group this week, giving the government's response to the report published by the Group in May following its inquiry into drug shortages. The report had concluded that the shortages were largely due to the export of medicines intended for NHS patients to other European Union (EU) countries.

The Minister also told the meeting that he believes the situation is also getting slightly better, with shortages reported for only around 30 out of around 16,000 licensed products.

 Earl Howe disagreed with the Group’s recommendation that the government should consider the use of the public health exemption to free trade laws, as used elsewhere in the EU, to ensure medicines are no longer exported where this would pose a threat to patients. This exemption would not be justified in the UK, he said.

Nor did he accept the report's recommendations that the Medicines and Healthcare products Regulatory Agency (MHRA) should tighten its control over the number of wholesale dealer licenses, or adherence to the Best Practice Guidance for manufacturers, wholesalers and pharmacists which the Department of Health issued in February 2011 with the aim of ensuring that patients could receive any medicine within 24 hours of presenting a prescription at a pharmacy.

However, Earl Howe did agree that the quota arrangements introduced by some suppliers to tackle shortages should be looked at. Further guidance might be needed to ensure that these are sufficiently equitable and flexible, and pharmacists should be asked which arrangements work best, he suggested. Implementation of the Best Practice Guidance is critical, and it should include emergency supply arrangements, he added.

Some of those attending the meeting expressed disappointment at the government's responses to the shortage problem, but Martin Sawer, executive director of the British Association of Pharmaceutical Wholesalers (BAPW), told Pharma Times that, from the Association's perspective, "there has been some progress." 

The BAPW said it welcomes the Minister's commitment to continue working with key stakeholders to find solutions to the unacceptable delay in patients receiving some branded medicines, and specifically his stated aim to explore whether further guidance on quota arrangements might be necessary.

"We also noted that the Department of Health was a keen advocate for the benefit of buffer stocks of medicines, an issue the BAPW has been promoting, along with the Pharmaceutical Services Negotiating Committee (PSNC), ever since the shortages issue arose," said the Association.

The BAPW also welcomed Earl Howe's praise for the Association and other supply chain stakeholders for ensuring that there was no disruption to medicine supplies during the summer's Olympic and Paralympic Games, and his comment that the NHS was extremely positive about the "hard work and professionalism" shown by the supply chain businesses. This, he added, should inform collaborative solutions to the supply problems.

Mr Sawer commented that while a lot of detail was not touched on in the meeting, the All-Party Pharmacy group has focused attention on some key areas for improvement.

"The inquiry process has also ensured that the benefits of the existing flexible and resilient wholesaler network are gradually becoming seen by all as the solution to branded medicine delays. The collaborative work BAPW led in preparing for the two Olympic Games periods this summer was testament to this,” he said.