prescriptions labelling and records

What legislation governs dispensing labels for medicines supplied against prescriptions?

HMR 2012 Regulation 258 and Schedule 25.

What is a dispensing label?

The pharmacy label added when a prescription is dispensed.

How does a dispensing label differ from manufacturer labelling?

A dispensing label is added by the pharmacy, whereas manufacturer labelling is governed by Regulation 257 and Schedule 24.

Why is correct dispensing labelling important?

Incorrect labelling can create both legal and patient-safety problems.

What information must appear on a dispensing label?

Product name, directions for use, precautions, patient name, date of dispensing, pharmacy name and address, and a child-safety warning.

Why must the product name appear on a dispensing label?

To identify the medicine supplied.

Why must directions for use appear on a dispensing label?

To tell the patient how to use the medicine safely.

Why must precautions appear on a dispensing label?

To provide necessary warnings and cautions.

Why must the patient's name appear on a dispensing label?

To link the medicine to the intended patient.

Why must the date of dispensing appear on a dispensing label?

To provide an audit trail and context for use.

Why must the pharmacy name and address appear on a dispensing label?

For traceability.

What child-safety warning must appear on a dispensing label?

'Keep out of the reach of children' or similar wording.

What label information can a pharmacist amend in limited circumstances?

The product name, directions for use and precautions.

What must a pharmacist not change when amending a label?

The prescriber's clinical intention.

What should never be confused with dispensing-label requirements?

Manufacturer pack-labelling requirements.

What legislation governs pharmacy records for POM supplies?

Regulation 253 and Schedule 23.

In which situations are Regulation 253 records most commonly required?

Private prescriptions and emergency supplies.

Why are NHS prescriptions usually not recorded under Regulation 253?

They are normally processed through NHS systems and the NHSBSA.

What must be recorded about the date of supply?

The date the medicine was sold or supplied.

What medicine details must be recorded in a pharmacy record?

The medicine name, quantity, form and strength unless strength is apparent from the name.

What prescriber information must be recorded?

The prescriber's name and address.

What patient information must be recorded?

The patient's name and address.

What prescription-date information must be recorded?

The date on the prescription.

When must a Regulation 253 record be made?

On the day of supply or, if not reasonably practicable, the following day.

How long must private-prescription records be kept?

For 2 years.

When is an additional Regulation 253 record not required for controlled drugs?

When a separate record has been made in the Controlled Drugs Register.

What two dates are commonly confused in pharmacy records?

The prescription date and the date of supply.

What is the recommended order for completing a private-prescription record?

Patient details, medicine details, prescriber details, prescription date, supply date, then reference number and price.

What are the two routes for emergency supply by a pharmacist?

Practitioner request and patient request.

Which regulation covers emergency supply at the request of a practitioner?

Regulation 224.

Which regulation covers emergency supply at the request of a patient?

Regulation 225.

What is the key feature of an emergency supply at a practitioner's request?

A prescriber requests supply because they cannot provide a prescription immediately.

What is the key feature of an emergency supply at a patient's request?

The patient requests the medicine and the pharmacist must ensure the legal conditions are met.

What must a prescriber undertake during a practitioner-request emergency supply?

To provide a prescription within 72 hours.

How must the medicine be supplied during a practitioner-request emergency supply?

In accordance with the prescriber's directions.

What controlled-drug restriction applies to practitioner-request emergency supplies?

Controlled drugs are excluded except phenobarbital or phenobarbital sodium for epilepsy.

What record requirement applies to practitioner-request emergency supplies?

A record must be made under Regulation 253 and Schedule 23.

What must a pharmacist do during a patient-request emergency supply?

Interview the patient or person requesting the medicine.

What must the pharmacist be satisfied about before making a patient-request emergency supply?

That there is an immediate need for the medicine.

What must be true about obtaining a prescription for a patient-request emergency supply?

It must be impracticable to obtain one without undue delay.

What prescribing history is required for a patient-request emergency supply?

The medicine must previously have been prescribed by a relevant prescriber.

What must the pharmacist be satisfied about regarding the medicine during a patient-request emergency supply?

The appropriate dose.

What record requirement applies to patient-request emergency supplies?

A record must be made under Regulation 253 and Schedule 23.

What is the maximum emergency-supply quantity for insulin?

The smallest pack available for sale or supply.

What is the maximum emergency-supply quantity for an asthma aerosol?

The smallest pack available for sale or supply.

What is the maximum emergency-supply quantity for an ointment or cream made up elsewhere?

The smallest pack available for sale or supply.

What is the maximum emergency-supply quantity for an oral contraceptive?

One full treatment cycle.

What is the maximum emergency-supply quantity for an oral liquid antibiotic?

The smallest quantity sufficient for a full course.

What is the maximum emergency-supply quantity for a Schedule 4 or 5 Controlled Drug?

5 days' treatment.

What is the maximum emergency-supply quantity for any other POM?

30 days' treatment.

Can Schedule 2 and Schedule 3 Controlled Drugs generally be supplied in an emergency?

No, except phenobarbital for epilepsy.

What additional wording must appear on a patient-request emergency-supply label?

'Emergency Supply'.

What additional information must be recorded for a patient-request emergency supply?

The nature of the emergency.

What is a requisition?

A formal request for a medicine or supply.

What is a signed order?

A requisition made in writing and signed by an entitled person.

Is a signed order a prescription for a named patient?

No.

For what purpose are signed orders commonly used?

Professional-use supplies where a legal exemption allows supply.

What should a pharmacist check before supplying against a signed order?

The requester, medicine, quantity, purpose and legal exemption.

Does a signed order itself provide authority to obtain any POM?

No.

What must be included in a correctly structured professional-use order?

The medicine requested, quantity, requester details, professional role, signature and date.

Who must sign a signed order?

The person whose legal entitlement is being used.

What must be true about the medicine requested on a signed order?

It must be permitted under the relevant exemption.

What should be clear on a professional-use signed order?

The quantity requested and intended professional use.

What is the legal basis for the professional-use examples taught in this session?

Regulation 235 and Schedule 17.

What is the key difference between a prescription and a signed order?

A prescription is for a named patient, whereas a signed order is for authorised professional use.