Collection of dispensed controlled drugs + Record keeping including CD registers

What must a pharmacist legally do before supplying a Schedule 2 controlled drug to a collector?

Determine who the collector is (patient, representative, or healthcare professional).

What should a pharmacist do if a patient or representative collects a Schedule 2 controlled drug?

May request proof of identity (at pharmacist’s discretion).

What additional details should be requested if a healthcare professional collects a Schedule 2 controlled drug?

Their name, work address, and proof of identity.

What is good practice when supplying Schedule 2 or 3 controlled drugs regarding signatures?

The collector signs the back of the prescription.

Which schedules must be recorded in a Controlled Drugs (CD) register?

Schedule 2 drugs (and Schedule 1 if handled).

Which Schedule 4 drug is recommended to be recorded in a CD register?

Sativex (Schedule 4 Part I)

What format must a paper CD register have?

A bound book

How must CD register entries be organised?

• Separate sections for each drug class

• Separate page for each strength and formulation

How long must a CD register be kept after the last entry?

2 years

Where must a CD register be kept?

At the premises to which it relates

Within what time frame must CD register entries be made?

Within 24 hours

In what order must CD register entries be recorded?

Chronologically

Can CD register entries be altered or erased?

No — no alterations, cancellations, or obliteration

How should errors in a CD register be corrected?

By a dated note in the margin or bottom, with name/signature and GPhC number

What details must be recorded when receiving controlled drugs into the pharmacy?

• Date received

• Supplier name and address

• Quantity received

What details must be recorded when supplying Schedule 2 controlled drugs?

• Date supplied

• Name and address of recipient

• Authority to possess

• Quantity supplied

• Who collected (patient/rep/HCP)

• If ID was requested

• If ID was provided

What three legal requirements must electronic CD registers meet?

• Attributable (who made entry identifiable)

• Auditable (log of entries available)

• Compliant with best practice

Can entries in electronic CD registers be edited later?

No — must not be altered

What must electronic CD registers be able to do for inspections?

Be printed and accessible at the premises

What is the purpose of a running balance in a CD register?

To detect discrepancies and irregularities quickly

How often are CD stock checks usually carried out?

Typically weekly (but depends on SOP)

Who has overall legal responsibility for controlled drugs in a pharmacy?

The pharmacist

Can responsibility for CD register entries be delegated?

Yes (to competent staff), but legal accountability remains with the pharmacist

What should be done if a CD discrepancy cannot be resolved?

Investigate fully and notify the CDAO (Controlled Drugs Accountable Officer)

Is a POM book entry legally required for Schedule 2 CDs dispensed on private prescription?

No (CD register entry is sufficient)

What is best practice for private Schedule 2 CD prescriptions?

Record in both CD register AND POM book

How long must invoices for Schedule 3 and 5 controlled drugs be kept?

2 years

How long does NICE recommend keeping invoices?

6 years

Within what time must CD register entries be made?

24 hours

How long must CD registers be kept?

2 years

What schedule requires the most strict register keeping?

Schedule 2