Human Medicines (Amendment) Regulations Debate

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Department: Department of Health and Social Care

Human Medicines (Amendment) Regulations

Lyn Brown Excerpts
Monday 18th March 2019

(5 years, 8 months ago)

Commons Chamber
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Philippa Whitford Portrait Dr Whitford
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That is the key thing: they do not have the patient’s records and they do not know what problems a drug may have caused in the past.

This change could have a real impact on epileptics. It brings the danger of a fit, and the fit itself may be a threat to them. Obviously epileptics are exposed to sudden unexpected death in epilepsy and can suffer from trauma, depending on where they are when they take the fit. They can even lose their driving licence for a year because they have one fit. The social impact of that on epileptics is enormous.

It says in the explanatory notes that, because of that, epilepsy drugs and biological drugs would not be considered suitable for the protocol. However, it does not say that in the SI—they are not excluded. It is important that such people are protected.

Lyn Brown Portrait Lyn Brown (West Ham) (Lab)
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I have been listening closely to the hon. Lady. This is already happening. A friend of mine went to her chemist to pick up some drugs and the dosage was halved by the pharmacist, not by her doctor. She had enough drugs to keep her going until she went to the doctor again, who reinstated the original drug. I just think it is really scary at the moment; people do not understand why this is happening. It cannot be about Brexit, because it is happening now.

Philippa Whitford Portrait Dr Whitford
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I am just coming on to that issue. I reiterate that it is the strength, rather than the dose, so I imagine the hon. Lady’s friend would be expected to take two smaller tablets, not to reduce her dose.

As I have said, the obvious thing would be to share the protocol with the prescribers, not to aim it at the pharmacists who are right at the end of the process.

Why is it that we are seeing the shortages now? Quite simply, there are two ways to stockpile: either by forcing increased production, which it is not necessarily within the gift of the Department or even the Secretary of State to do, or by setting aside some of the drugs within normal production. When I talk to my GP friends, they talk about a massive surge in shortages over the past nine months. That coincides almost exactly with the acceleration of stockpiling. My concern is that drugs are being set aside into the stockpile and that is causing shortages right now.

There should be publication of the list of drugs that are at risk of shortage, so that a GP can say, “For this lady or gentleman it is not that important, so if it is a shortage drug I won’t use it, but for this other patient I will have to use it.” Apparently, that is currently hidden behind commercial sensitivity.

It is important that a consultation and an impact assessment are carried out. I was shocked that the BMA was given a week to respond and the General Medical Council was not even consulted. This statutory instrument totally reverses medical and prescriber legal responsibility, so who is legally responsible? How do pharmacists feel about the fact that they might be held answerable for changing the drug, or will the Government underwrite that? I think that this has been appallingly handled and has been snuck in with no scrutiny and no debate.

The hon. Member for Leicester South (Jonathan Ashworth) talked about cost and time saving for GPs and, secondary to that, the impact on patient safety. If we look at the basis for the review in a year, it says that No. 1 will be the function of the market and that No. 2 will be the impact on patients, so again we see that patient safety is not being put at the heart of this. This proposal has not been properly thought through, particularly if it is envisaged as a long-term solution to drug shortages. No deal should now be off the table, as of last week. There should be time to look at this issue properly, consult properly and come up with something that will not endanger patients.