Prescribing crackdown

With reports of many commonly prescribed prescription drugs in short supply, and ongoing concerns about medicines supply post-Brexit, you may have missed the news that more drugs have been ‘blacklisted’ and should no longer be prescribed on the NHS

Apparently, the current financial problems in the NHS can be attributed to primary care prescribing. You may have thought that austerity economic policies were in some way responsible, but guidance from the NHS Clinical Commissioners (NHSCC) in June this year lays the blame firmly at the door of profligate general practices.¹ The NHSCC reported that in 2018, 1.1 billion prescriptions were issued from primary care (a number that is rising with time²) at a cost of £8.8 billion (a reduction from previous years³). With the spend on the NHS being about £125 billion a year, if primary care just stopped issuing prescriptions completely there would be a saving of just over 7%.

IS GUIDANCE NEEDED?

There are many good reasons to prescribe efficiently and effectively. A medication that does not work cannot possibly do any good, but it may nonetheless have side effects and interact with other medications. A medicine may be no longer needed – it was useful once, but now can be withdrawn without ill effects. A mindset among prescribers that medication is not the answer to all problems encourages discussion with patients and a search for a more effective treatment option. Resources that are not spent on drugs can theoretically (but not inevitably) be spent on other useful things.

Good prescribing is also a professional requirement for nurses and doctors. The NMC Code includes a professional requirement to prescribe in your patients’ best interests as does (in similar language) Good Medical Practice from the General Medical Council. But whatever the motivations are to prescribe effectively, this report is mainly concerned with saving money, which is why the need to reduce prescribing costs is at the very top of the NHSCC’s rather brief list of reasons for their guidance – paragraph 1.2.¹

The amount that the NHS spends on medications depends, among other things, on the cost of the medication. Sometimes, for no apparent reason, the manufacturer raises the cost of one of its products. According to the NHSCC methodology (see paragraph 1.31) this should lead to an examination to see if the product should be added to the restricted list on cost grounds.¹ Then the price might come down again, causing further chaos as patients start taking it again. Changing a patient’s medication, whatever the reason, involves work for the healthcare professional.

However, another reason given in the NHSCC report for producing the guidance centrally was to avoid duplication of work by practices and CCGs who were ‘having to take individual decisions about local formularies’.

CONTROLLING PRESCRIBING COSTS

This is not the first attempt at curbing primary care prescribing. The Limited List was first introduced on 1 April 1985, when Margaret Thatcher was PM, and Norman Fowler was the Secretary of State for Health and Social Services. At the time it was seen by many in primary care as quite a logical move, seeing as the banned list included such therapeutic necessities as baked beans and creosote. It had minimal effect on prescribing costs.⁶ The Limited List still exists as section XVIIIA of the NHS Drug Tariff. On the current list are Gales Honey, Ribena and Perrier Mineral Water.⁷ The list is enforced by the simple expedient of the dispensing pharmacist not being eligible for reimbursement of the costs of the listed items: in general a withholding of money is an effective deterrent in such circumstance. No new treatments have been added since 2004.

During the 1980s and 1990s many primary care practices developed their own formulary of drugs recommended for prescription treatments. This dovetailed nicely with the rise of practice audits and performance reviews, and prompted practices to go through a multidisciplinary educational exercise where evidence for drug use could be examined and critiqued. Practices that developed nurse triage also underwent a process where clinical protocols were developed, including policies about what drugs to prescribe and when.

The current NHSCC report is the second in a series – the first was published in July 2017. Version 2 includes guidance on 25 different individual medications or whole treatment genres. Annual NHS costs are also given for each of the 25 items: the lowest cost is attributed to homeopathy treatments, the highest is for insulin pens. For many items there is also a comparison with the spend when the first NHSCC report was produced, which shows that for a number of items (but not all) the NHS costs have fallen, so presumably the first report had some impact. The total current spend on all the 25 items adds up to just over £136 million: if all these could be stopped then the saving to the NHS would be just over 0.1% of its total budget.

The full list can be found in Table 1. The list is designed to be incorporated into individual CCG formularies. Advice is offered that items on the list might fall into a number of categories:

• Should not be initiated in primary care
• Prescribers supported to ‘deprescribe’ the item. Support is available from the Specialist Pharmacy Service,⁸ which is commissioned by the NHS to work as a single integrated service across all four regions of NHS England
• There may be exceptional circumstances (defined as ‘Where the prescribing clinician considers no other medicine or intervention is clinically appropriate and available for the individual’) where an item can be used, but only in the context of a discussion with another healthcare professional or a multi-professional team (the nature of such a team is not defined).
• Prescribing only by a specialist
• ‘May be prescribed in named circumstance’ (it is not defined what those circumstances might be).

It will be seen that the provisions of the guidance are very far from being a bar on prescribing. The Limited List is a proscribed list, and cannot be got around. This new guidance will prove relatively easy to bypass if necessary, should the clinical need or relations with the patient require it. The guidance also contains the sentence:

‘The guidance does not remove the clinical discretion of the prescriber in accordance with their professional duties.’

This is perhaps as well. The Terms and Conditions which regulate the relations between GPs and the NHS include the clause:⁹

14.2.2. ‘...a prescriber shall order any drugs, medicines or appliances which are needed for the treatment of any patient who is receiving treatment under the Contract...’

As well as considering each item in terms of clinical effectiveness, safety, whether there is an alternative, and the financial implications, decisions considered possible ‘Unintended consequences’ of their recommendations.¹ In this author’s view, it is not clear whether impact on workload was one of them. Not initiating treatment is relatively easy in organisational terms. But what about ‘deprescribing’ – swapping patients onto alternative treatments, or stopping them. This will require extra consultations with a nurse or doctor, at a time when general practice is stretched to breaking point and patients are already complaining about the difficulties in getting an appointment. Perhaps the current short list of items will not amount to much with respect to extra consultations. But in the space of 2 years, extra items have been added to the list, and this process of additions will probably continue.

SOME POINTS IN DETAIL

When performing a clinical a trial of a treatment, the overall statistical result may well show no benefit, or even worse, shows that it does harm. But this conclusion will be as a result of adding up results from individual patients, some of whom will have got some benefit even if the overall cohort effect is nil. This is a quirk of evidence, and though it is the best we have, that does not mean that for individual patients it cannot or will not be challenged. At least some patients will be convinced that the treatment worked for them. This is a particular issue for enthusiasts of herbal treatments and homeopathy, which the NHSCC guidance rejects completely. Indeed the British Homeopathic Association has already legally challenged the exclusion of its treatments from NHS prescribing – it lost.

Some recommendations in the guidance are driven entirely by cost, even to the extent of including a price criterion for insulin needles. The Drug Tariff price of slow release doxazosin is about five times the price of the immediate release version.¹⁰ The immediate release version only has to be taken once a day anyway, so slow release confers no advantages. The combination of paracetamol and tramadol is outlawed, because it is more expensive than the individual components. However, paying one prescription charge rather than two makes combined tablets popular. What is cheaper for the NHS might not be cheaper for your patient. From a therapeutic standpoint, being able to adjust the dose independently (which you can’t do with a combined tablet) has advantages especially as the therapeutic range of tramadol is much greater than paracetamol. In addition, the placebo effect appears particularly strong in relation to the effects of painkillers:11 this would imply that loyalty to a particular treatment is likely to be quite substantial, causing resistance to change.

Tadalafil has a licence for two problems: erectile dysfunction and benign prostatic hyperplasia. The first requires intermittent use of higher dose tadalafil, up to a maximum of once a day, and the circumstances in which it can be prescribed are set out in part XVIIIB of the Drug Tariff – https://www.nhsbsa.nhs.uk/pharmacies-gp-practices-and-appliance-contractors/drug-tariff. The latter requires lower daily doses. When NICE asked the manufacturers to justify the use of tadalafil in benign prostatic hypertrophy they were unwilling to provide any evidence of effectiveness, leading to the decision not to recommend. This begs the question of how many more manufacturers of licensed drugs are unable to provide proof that their product is any more than an expensive placebo. There must have been some compelling evidence once, or the licence would not have been granted. The continuing long-term use of a medication often provides evidence that the short-term trials prior to licensing have not picked up on.

Liothyronine is a synthetic form of triiodothyronine, or T3, which is the active metabolite of thyroxine. Dose for dose it is about four times stronger than levothyroxine, the synthetic form of thyroxine (T4). Available since 1956, it has an active and enthusiastic following on the Internet, including from people who claim a medical qualification.¹² It can be bought on Amazon.¹³ An underactive thyroid produces a number of symptoms including impaired memory and concentration, weight gain and fatigue. So having a little pill to make these things go away is quite a compelling idea (especially as once treatment for this condition is prescribed then all prescriptions, not just for the thyroid treatment, are thereafter free of NHS prescription charges). NICE prefers treatment with levothyroxine,¹⁴ a decision made easier because levothyroxine works just as well as liothyronine in most people, and between 2007 and 2017 the manufacturers put up the price of liothyronine by 1600%.¹⁵ The NHSCC guidance¹ accepts that some patients do better on liothyronine (either physically, psychologically, or both) and so treatment is acceptable if supported by a consultant endocrinologist. However, these are patients who would probably not otherwise be referred.

CONCLUSION

It is undeniable that prescribing efficiently and effectively is the right thing for healthcare professionals to do. It is supported by the available evidence and is incorporated into the codes of professional conduct for nurses and doctors. Issuing a prescription is, aside from referring them to hospital, the most dangerous thing that primary care practitioners do to their patients.

Making the changes proposed by the NHSCC will generate a workload, which is most unwelcome when primary care is already stretched to its limits. This report is already into its second iteration, and should be seen against a long tradition of trying to curb primary care prescribing. Out of a sense of professional duty, many practices have been trying to improve their prescribing for several decades anyway, and do not needed new guidance to do so.

The NHSCC report is primarily driven by a desire to save money. Other reasons are given in their publication, but talk of money is right at the top of the list so it is not hard to deduce the main motivation. The potential saving for the country is of the order of 1.5% of the primary care prescribing budget or 0.1% of the total NHS budget. The costs are to make work and undermine the professional integrity of practice nurses and GPs.

REFERENCES

1. NHS Clinical Commissioners. Items which should not routinely be prescribed in primary care: Guidance for CCGs. Version 2, June 2019. https://www.england.nhs.uk/medicines/items-which-should-not-be-routinely-prescribed/

2. Ewbank L, Omojomolo D, Sullivan K, McKenna H. For The King’s Fund. The rising cost of medicines to the NHS. What’s the story? April 2018. https://www.kingsfund.org.uk/sites/default/files/2018-04/Rising-cost-of-medicines.pdf

3. Buckle J, Hayward T, Aggarwal A, Chakravarty L. Milliman White Paper. How is the English NHS prescription drugs budget spent? 20 May 2019. http://assets.milliman.com/ektron/How_is_the_English_NHS_prescription_drugs_budget_spent_20190517.pdf

4. Nursing and Midwifery Council. The Code. https://www.nmc.org.uk/globalassets/sitedocuments/nmc-publications/nmc-code.pdf

5. General Medical Council. The duties of a doctor registered with the General Medical Council https://www.gmc-uk.org/ethical-guidance/ethical-guidance-for-doctors/good-medical-practice/duties-of-a-doctor

6. Irwin WG, Mills KA, Steele K. Effect on prescribing of the limited list in a computerised general practice. BMJ 1986;(293):857-9.

7. NHS Business Services Authority. Drug Tariff. https://www.nhsbsa.nhs.uk/pharmacies-gp-practices-and-appliance-contractors/drug-tariff

8. Specialist Pharmacy Service. https://www.sps.nhs.uk/

9. NHSCC, BMA, DHSC. Standard General Medical Services Contract.

10. NHS Electronic Drug Tariff. http://www.drugtariff.nhsbsa.nhs.uk/#/00446515-DC_2/DC00446511/Home

11. Marchant J. A Placebo Treatment for Pain. New York Times 9.1.16. https://www.nytimes.com/2016/01/10/opinion/sunday/a-placebo-treatment-for-pain.html

12. Welchel J. How to use liothyronine in hypothyroidism. Healthy Hormones. http://healthyhormones.us/liothyronine-in-hypothyroidism/

13. Amazon. Liothyronine

14. NICE. Hypothyroidism. https://cks.nice.org.uk/hypothyroidism#!scenario

15. Wickware C. CMA investigates 1,600% price increase of liothyronine over eight-year period. The Pharmaceutical Journal 31 JAN 2019 https://www.pharmaceutical-journal.com/20206079.article?firstPass=false