Human Medicines (Amendment) Regulations

Alison Thewliss 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.