ArticleAre Electronic CD registers legal?

We frequently get asked this question, so thought it best we discuss the answer in a post.

The short answer is "Yes". The slightly longer answer is "Yes. But only if they meet certain criteria".

At Clara, we have gone to great lengths to ensure that the Clara CD Register meets the current guidelines which, if you've got a copy of Medicines, Ethics and Practice 2019 to hand, you can see on page 107.

These guidelines stipulate that:

• Every entry needs to be attributable to someone
• Inspectors can audit the registers
• Registers can be printed
• Entries cannot be edited or altered after creation
• Access control systems are in place
• Backups are made of the registers

Clara's CD Register meets all of these guidelines. Let’s dig into that a little more and find out how Clara does it.

Every entry is attributable

Whether you are supplying stock from your CD Register, creating a new register for a drug or anything else, every entry in the Clara Controlled Drug Register requires you to select who is making the entry. This makes it easy to go back and see who made each entry, which is useful for audit purposes.

Auditable registers

Since the ways in which entries can be created and amended are strictly controlled, there is an inherent paper trail to all changes. To ease auditing and reduce the amount of time an inspector would need to tie up the dispensing computer, the backup register PDFs can easily be printed off. These printouts follow the same format as the paper registers. 

These backups are created automatically. However, there is also the option to create them manually.

Registers are printable

As mentioned above, every Controlled Drug Register in Clara can be exported as a PDF and printed out on A4 paper. The printout contains all the column headings specified by the legislation, as well as a useful running balance column.

We follow the common convention that the details of entries not related to booking stock in or recording stock given to a patient are written in the supplier name and address column.

Entries cannot be altered

There is no way for a user to edit or otherwise alter any entries in Clara, nor does the software provide any way for Clara staff to edit entries.

Once an entry is made, it cannot be changed — but it is possible to add timestamped “annotations” to an entry, similar to the way you might add notes in the margin of the paper register.

If you get the quantity wrong on an entry, you can explain the mistake in an annotation, and add another, separate, correction entry to fix the running balance.

Controlled access

To access any features in Clara, the user needs to log in with an email address and password. No users can access any of the data in the register without this username and password.

The data itself is encrypted at rest and in transit, never leaves the UK, and is stored with an industry-leading cloud provider.

Individual branch accounts cannot see the data from other branches.

Register backups

Clara backups up your CD Registers in 3 different ways:

Continual rolling backups

Logs are kept of all database changes, so we can restore to any given point in time. If something went wrong and the data was destroyed in some way, we'd be able to restore to the point right before the destroying operation.

Nightly snapshots

Every evening a copy is made of the entire database and stored for a period of time according to our backup and data retention policies. This means that even if the whole database and operation log became corrupted or lost, we'd still be able to restore to a very recent copy of the data.

Nightly PDF backups

Every evening, every register which has changed since the previous evening is exported to PDF.

The backed-up registers and PDFs are stored on a separate hosting service, so even if however unlikely, some sort of disaster were to destroy all our database backups, it would be very unlikely to also affect the PDF exports.

Important: this article is not legal advice. Pharmacists are individually responsible for following relevant laws and professional standards, and for determining whether Clara is right for their pharmacy.