Safety of Medicines and Medical Devices

Baroness Masham of Ilton Excerpts

Thursday 28th February 2019 Lords Chamber

[Baroness Masham of Ilton (CB)]

My Lords, when the noble Lord, Lord O’Shaughnessy, gave up his position at the Department of Health, many people were dismayed, as he was doing an excellent job. I am so pleased that he is still involved with the health service, and today is an example, as he has brought up the vital matter of safety in the NHS, particularly at this difficult time. I thank him for that. I also congratulate the Minister on taking on the mammoth task of looking after the interests of the NHS and social care.

In the past year, I have taken part in several All-Party Parliamentary Health Group evidence sessions on cancer and other disabling conditions. I found the overriding similarities between them to be late diagnosis of the condition and the problems arising from not having the correct medicines and treatment at the right time. At a recent seminar on safety, one of the main dangers highlighted was fatigue of doctors and nurses, risking them giving patients the wrong dosage or the wrong medicines. I understand how that can happen on a busy ward with a shortage of experienced nurses or during a 12-hour shift.

It is sad that the European Medicines Agency has already left London and gone to Amsterdam. Medicine regulation in the UK will be affected by our departure from the EU. With the EMA having left London, it has already begun. The Royal College of Surgeons is pleased to hear that the Government are considering the establishment of a national medical devices registry. Can the Minister give your Lordships a progress report on that matter?

I am so pleased to hear that NHS Improvement is delivering a new patient safety strategy. So many bodies work for the NHS that it is sometimes difficult to know which is doing what. Will that strategy look at the dangers of counterfeit medicines, many of which are available on the internet? Addiction to medicines is a growing problem.

It is estimated that 52,000 people in the UK die every year from sepsis, a serious complication of an infection. I declare an interest as I had it in the summer; I have been on antibiotics for more than six months. A new rapid test for the early diagnosis of sepsis is being developed by researchers from the University of Strathclyde. The device, which has been tested in a laboratory, may be capable of producing results in two and a half minutes.

In a recent report, NHS Improvement stated:

“Treating pressure damage costs the NHS more than £3.8 million every day”.


It also noted:

“Despite extensive prevention programmes, evidence suggests about … 2,000 patients a month develop pressure ulcers”.


Bruin Biometrics has produced an SEM scanner, which is used to address the problem of pressure ulcers. It is a wireless, hand-held device designed to be an adjunct to clinical assessments; it can alert clinicians to incipient pressure damage not visible at the skin’s surface. It is encouraging that these useful devices are being developed so that prevention can avoid many medical problems.

In August 2018, NHS Improvement issued a patient safety alert after 35 people died from cardiac arrest due to hyperkalaemia, or elevated potassium levels. What support is the Department of Health and Social Care giving providers to ensure that they can comply with requirements to test for and treat that condition? Should not guidelines go out to trusts and GPs? High potassium is a danger to kidney patients because their medication can cause high serum potassium, which is dangerous for the heart and can cause cardiac arrest. On the other hand, low potassium levels can be a danger for people with spinal injuries, so more attention should be paid to potassium levels.

Sodium valproate has been discussed by two noble Lords. It is a drug which has put pregnant women with epilepsy in danger of having children who are autistic. This unfortunate case illustrates the need for clear and honest information along with accurate data. Good communication should be set up between hospitals and GPs, patients and carers, voluntary organisations and public health, and prison health and regulators. All stakeholders should communicate where necessary and should work in harmony, not in isolated silos. What is difficult for patients is when they are given conflicting advice and views. This has been a big issue on the Patients Association helpline. There is much to do, and I look forward to hearing the maiden speech and the Minister’s reply.