Human Medicines (Amendment) Regulations

Philippa Whitford Excerpts

Monday 18th March 2019 Commons Chamber

[Dr Philippa Whitford (Central Ayrshire) (SNP)]

We are discussing changes to the Human Medicines Regulations 2012. I welcome the implementation of the falsified medicines directive, with its provisions on unique identifiers and anti-tampering devices. I also welcome the change to allow nasal naloxone to be used to deal with opioid overdose. But snuck in among those perfectly reasonable measures is the serious shortage protocol. That deals with prescription-only medicines and highlights what we face with Brexit coming in 11 days.

Forty-one million packets of drugs a month go from the UK to the EU, and 37 million are imported into the UK, including almost all insulin—the UK does not produce insulin to a large extent. There are many other drugs that the UK does not produce. We have previously and in this debate raised the issue of radioisotopes, although this clearly does not apply to that. There will also be problems with the supply chain of raw chemicals to produce drugs in the UK and with processes such as batch testing for UK exports into the EU, because the EU will not recognise batch testing not carried inside the EU. One of the key words missing from the withdrawal Act that was scattered throughout the Chequers deal, if we can call it that, is “frictionless”. Do a word search. It is not there. We have been discussing this matter in the context of no deal, but there will be issues regarding the supply chains in making drugs and moving drugs around even if the Government’s withdrawal agreement goes through.

Bizarrely, section 8 of the explanatory memorandum to the regulations claims:

“This instrument does not relate to withdrawal from the European Union.”

As we would say in Scotland, “Aye, right.” It continues that:

“if withdrawal from the European Union were a contributing factor to a serious shortage…a serious shortage protocol could be used”.

That is the thinnest fig leaf I have ever seen in my whole life.

The documents talk about the Minister or Ministers being able to add drugs to the serious shortage protocol list. Who is meant by “Ministers”? Is it the devolved Ministers in Edinburgh and Cardiff, or are we merely talking about all the junior Ministers and the Secretary of State here in Westminster? Health is devolved, and the use of drugs and the diseases dealt with vary across the UK. It is important that health is not pulled back away from devolution. I would like that to be clarified, particularly when the Minister suggests that this is not a short-term solution, but envisaged as a long-term solution for shortages.

I accept that shortages can arise, but normally they are few; normally it is possible to get access to information about what is causing them, making it easier to come up with solutions. However, as has been said, the review will take place only after a year, which is quite a long time for a protocol to be in place. It would be useful to send information on what replacements could be used to the GP or prescriber, rather than to the pharmacist. If it is known that there is a national shortage, why wait until the point of dispensing the drug? Tell GPs. Tell non-GP prescribers. Do not leave it to the last minute, when someone is in the pharmacy. That is the issue: the shortage protocol gives pharmacists the power to override the prescriber. Predominantly, that is a GP, but not necessarily.

I say to other Members that pharmacists can change the strength, but not the dose. If someone is on a 10 mg tablet and is used to taking one 10 mg tablet, they may be given two 5 mg tablets. That may seem innocuous, but an elderly, vulnerable or slightly confused patient who knows that they take one tablet every morning might end up taking half the dose they require. Even worse is if they are given a larger dose that they are meant to cut in half. That is much more complex. The number of tablets patients have to take could cause confusion.

The statutory instrument talks about quantity. At the moment, patients are usually given eight weeks of a prescription and pay a prescription charge. If they only get four weeks of their medication, will they get the second four weeks without paying another prescription charge or will prescription charges be doubled? That is not an issue in Scotland, but it is certainly an issue here in England.

[Alison Thewliss (Glasgow Central) (SNP)]

My hon. Friend is speaking very knowledgably about dosage. Many of my constituents are on methadone prescriptions. They need to get the correct amount of prescription or it can have very real consequences for relapse and how they are able to live their lives. Does she agree that protections need to be put in place for groups for whom removing the dose could have severe consequences?

[Dr Whitford]

It is critical that the patient’s dose is not changed or put in danger. The management of any condition is dose sensitive. We cannot go down to homeopathic doses of antibiotics or blood pressure medication—that would be crazy.

Pharmacists can give a different form, such as liquid, solid or capsule. Again, for some patients that will not be a problem; for others, it will. The hon. Member for Newton Abbot (Anne Marie Morris) mentioned generic drugs. Generally, NHS prescribers use generic drugs as the default to save money. However, I have had patients who had appalling side effects from the generic form of tamoxifen, but not from the non-generic brand. There always has to be a right for GPs to say, “In this case, I will use the brand.”

The most important bit of this statutory instrument is that it allows a change to a completely different drug. It may be a drug that is approved by a panel sitting somewhere in London with the colleges, who say that it is a reasonable replacement for the other drug, but that does not take into account the fact that patients are all individuals. I can tell you that they are all individuals.

Pharmacists are very knowledgeable—in Scotland, we have had community pharmacists for over a decade and they contribute massively—but they work to their own protocol, they work within limits and they do not have access to the patient’s notes. Therefore, they cannot see that the patient has been on a drug in the past and had terrible side effects. They will replace with a protocol drug, but what about the responsibility? Why is this happening right now?

It suggests to me that the Department of Health and Social Care is expecting massive shortages, to the point where the simple act of picking up the phone and saying to the GP, “I don’t have drug A. Would drug B be reasonable for Mrs Smith?”, is somehow impractical. I find that very worrying. It may be that Mrs Smith has had six drugs to control her blood pressure. Drug 2 and drug 5 caused her to faint or have blackouts, but the pharmacist does not know that.

Epileptics have been mentioned. The issue with epileptics is that any change can destabilise their epilepsy. They are therefore never prescribed by generic, but are prescribed by brand to avoid precisely that.

[Norman Lamb]

The hon. Lady makes a very good point. Does she agree that there is often an interaction between epilepsy drugs and other drugs that the patient may be on and that any interruption of that relationship may cause problems?

[Dr Whitford]

The right hon. Gentleman makes a very good point, and one that applies to many drugs. When we prescribe, we sit and look at the interactions. I would expect a pharmacist to look at that. They will have the patient’s full prescription and should, therefore, be able to look at interactions.

[Norman Lamb]

They do not have the patient’s records.

[Dr Whitford]

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 (West Ham) (Lab)]

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.

[Dr Whitford]

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.