Why Controlled Drug Prescriptions Still Require Hardcopy Signed in Indelible Ink in a Digital World

The short answer is section 15 of the Misuse of Drugs Regulations 2001.

However, this should not be the case. Technology has advanced to the point that makes this law obsolete. We are now using digital prescriptions for all medicines but controlled drug. It solved many problems and make healthcare more accessible.

Errors due to illegible prescriptions have mostly disappeared. In primary care, NHS BSA developed the eFP10 system which enables fully digital prescriptions even for controlled drugs. This is the only known exception to the indelible ink requirement as we all know.

But why do the private and hospital sectors still have this requirement? I think it's because most, if not all, pharmacists remain cautious. They can exercise their discretion to refuse to dispense prescriptions if they are legally invalid. Missing the indelible ink requirement would count as legally invalid and thus, to avoid operational chaos, private and hospital providers choose to keep this requirement.

But first, let's step back. What does the law say? The law is actually made by secondary legislation. Section 15 of the Misuse of Drugs Regulations 2001 is the basis for this indelible ink requirement. Until this is repealed, it remains the law. It was not made by Parliament, but rather by civil servants on behalf of the ministers exercising their power to legislate. Brushing constitutional arguments aside, law-making in this way is much easier to reform as it does not need the usual parliamentary legislative process but rather the secondary legislation process, though that is resource intensive. Nevertheless, no reform has been done in this area.

The main point here is that there was no reform because there was no policy drive to change it and no business case for doing so.

If we trace back the law, we will see that it originates from the Misuse of Drugs (Safe Custody) Regulations 1973, which is a statutory instrument — also a secondary legislation. It doesn't make it any less of a law but in theory, it is easier to reform than primary legislation. The Shipman case reinforced the case for the law requiring indelible ink and thus, the law remains as it is.

But we are not in 1973 let alone 2000. Technology has evolved such that digital systems can and have solved the forgery problems that indelible ink was meant to prevent.

I was working at an offsite outpatient hospital dispensary. A prescriber, based on site, prescribed methylphenidate, a Schedule 2 Controlled Drug, for an outpatient. Trust policy requires an original signed hardcopy before dispensing, sent to the onsite outpatient pharmacy. Once this is received, the offsite will receive notification from the onsite pharmacy and we will start the dispensing process. However, in this case, the prescriber sent it to an inpatient pharmacy instead of the outpatient pharmacy which meant that the dispensing process was not triggered. The patient called asking for their medication. We had to contact the prescriber to resend it. Delay of about 72 hours. The patient ended up collecting it from the onsite pharmacy instead, defeating the purpose of our hub and incurring additional charges to both the patient and the Trust. This is not a clinical safety failure. This is a process failure caused by a system that still depends on paper.

At the system level, the problem repeats monthly. The offsite pharmacy receives the signed CD hardcopy from the onsite pharmacy. We are supposed to reconcile the hardcopies they post to us against the supplies we dispensed. In the most recent cycle, I found signed hardcopies with no corresponding supply and supplies with no corresponding hardcopy. Even with the reconciled supplies, there were countless prescriptions where the date on the hardcopy and the prescription date on the supply record did not match. This is expected behaviour because the date is auto-generated based on the printing time. The issue is that there is a gap in accurate record-keeping of when the prescription was actually signed. Not an issue per se but adds to the difficulty in reconciling the prescriptions. I then need to do detective work, looking through the records, contacting the prescribers and even asking the prescriber to sign a new hardcopy. Despite all this, some couldn't be reconciled. It made me wonder what value I add by doing this.

One would say that we are safeguarding clinical governance and to that I will say that is not true. The digital system itself safeguards against unauthorised issuance of prescriptions. For the purpose of offsite pharmacy operations, reconciling the hardcopy prescription with supplies adds no clinical value. Despite that, we still do it and the workload is not even accounted for in the staffing resources available. We are just expected to do it and when we are unable to, the work gets rolled over to the next month until eventually it gets discovered due to some investigation, leading to regulatory risk. It is a signal that the system is not working. It is designed around a constraint that no longer serves a clinical need. But not doing it is not an option either due to the regulatory risk.

It is becoming a chicken and egg situation. We can't get out of the problem as we need to do it but there is no business case for changing it. We simply get on.

I am clear on the intuition and the inefficiency but have no means to change it. We need a business case to change it and we need data to make a business case. But there is no data to use. So we need a measurement system that captures the waste without adding work. I think AI could help with that.

The NHS is investing in AI across many domains including operational efficiency. One possible workstream is a tool to identify waste in existing processes and make it easier for frontline staff to make a business case for changing the process. The tool makes invisible waste visible. This is exactly what we need. Some would say that our systems already have it. I would say that is inaccurate. With every digital system the Trust uses, each team builds their own custom solutions. The number of Excel spreadsheets I have worked with is the proof. I am grateful and impressed with the creativity of the people who design these spreadsheets. But over time, they become clunky and burdensome, designed to solve some pain points for staff but overall inefficient. So that is why the first step is to measure waste so that we can make a case for improving it.

I don't yet know the shape of this tool. But measurement is where it starts. This is what I'm planning to build next. If you have any ideas, do let me know. I would love to work with you.