controlled drugs

What is the difference between a Misuse of Drugs Act class and a Misuse of Drugs Regulations schedule?

Class relates to criminal classification and penalties, while schedule determines pharmacy controls.

What are the Misuse of Drugs Act classes?

Class A, Class B and Class C.

What are the Misuse of Drugs Regulations schedules?

Schedules 1 to 5.

Which system is most important for pharmacy practice?

The Misuse of Drugs Regulations schedules.

What does a CD schedule determine?

Possession, prescribing, supply, storage, records, requisitions and destruction requirements.

What is the memory aid for controlled-drug classification?

Class = criminal classification, Schedule = pharmacy controls.

What is Schedule 1 used for?

Substances with no recognised routine medicinal use that usually require a Home Office licence.

Which schedule has the strictest routine pharmacy controls?

Schedule 2.

What controls apply to Schedule 2 controlled drugs?

Special prescription requirements, 28-day validity, safe custody, CD register entries, collection checks and witnessed stock destruction.

Give examples of Schedule 2 controlled drugs.

Morphine, oxycodone, fentanyl, methadone and diamorphine.

Do Schedule 3 CDs have the same prescription requirements as Schedule 2 CDs?

Yes.

Do Schedule 3 CDs have 28-day prescription validity?

Yes.

Do Schedule 3 CDs require CD register entries?

No.

What is the key difference between Schedule 2 and Schedule 3 regarding records?

Schedule 2 requires CD register entries, while Schedule 3 does not.

Does safe custody apply to all Schedule 3 drugs?

No, only specified Schedule 3 drugs such as buprenorphine, temazepam and diethylpropion.

Are Schedule 3 CDs generally eligible for emergency supply?

No, except where a specific legal exception applies such as phenobarbital.

What additional requirement applies to Schedule 3 CDs?

Requisition requirements.

What types of medicines are commonly in Schedule 4 Part I?

Many benzodiazepines and Z-drugs.

What type of substances are commonly in Schedule 4 Part II?

Anabolic and androgenic steroids and related substances.

How long are Schedule 2, 3 and 4 prescriptions usually valid?

28 days.

What type of products are generally found in Schedule 5?

Low-strength preparations with less restrictive controls.

How long are Schedule 5 prescriptions normally valid?

6 months.

What should you ask yourself when reviewing a controlled-drug prescription?

What substance is it, what schedule is it in, what route is being used and what controls apply?

What details must be included on a Schedule 2 or 3 CD prescription?

Patient name and address, drug name, form, strength, quantity, dose, prescriber signature, prescriber address and date.

How should quantity be written on a Schedule 2 or 3 prescription?

In both words and figures.

Must the dose be stated on a Schedule 2 or 3 prescription?

Yes.

Is 'as directed' usually sufficient for a Schedule 2 or 3 prescription?

No.

Why must form and strength be clear on a CD prescription?

To identify exactly what is being supplied.

Can a legally complete CD prescription still require professional intervention?

Yes, if the dose, quantity or form appears unusual.

What is the validity period for Schedule 2, 3 and 4 prescriptions?

28 days.

What is the appropriate date of a CD prescription?

The date signed or a later start date specified by the prescriber.

Must an owing balance be supplied within the validity period?

Yes.

What is considered good prescribing practice for Schedule 2, 3 and 4 CDs?

Usually no more than 30 days' treatment unless justified.

Can pharmacists amend some Schedule 2 and 3 prescription errors?

Yes, but only within limited legal powers.

What types of amendments may a pharmacist make to a Schedule 2 or 3 prescription?

Minor spelling errors, minor typographical errors and adding missing words or figures where quantity is already clear.

What changes may a pharmacist not make to a Schedule 2 or 3 prescription?

Drug, dose, form, strength, patient details, prescriber details or date.

What should be done if the prescriber's intention is unclear?

Contact the prescriber.

What form is used for private Schedule 2 and 3 CD prescriptions in England?

FP10PCD.

What extra requirement applies to private Schedule 2 and 3 CD prescriptions?

A prescriber identification number.

Can non-CD POMs be mixed with Schedule 2 or 3 CDs on a private CD form?

No.

When is possession of a controlled drug lawful?

When there is a legal authority such as a prescription, requisition, pharmacy business authority or licence.

Which schedules require CD register entries for pharmacy receipt or supply?

Schedules 1 and 2.

Do Schedule 3 CDs require CD register entries when received or supplied by a pharmacy?

No.

What is safe custody?

The physical security of controlled drugs.

Which CDs are subject to safe custody requirements?

Schedule 2 CDs and specified Schedule 3 CDs.

Where must CDs subject to safe custody normally be stored?

In an appropriate locked cabinet or safe unless under direct supervision.

What should be considered when applying safe custody rules?

The schedule, drug, storage requirements and SOPs.

What collection information should be recorded for Schedule 2 CDs?

Whether the collector was the patient, representative or healthcare professional and whether ID was requested and provided.

Does lack of ID automatically make a Schedule 2 supply unlawful?

No.

What is good practice when collecting Schedule 2 or 3 CDs?

Obtain a signature or record who collected the medicine.

What is the purpose of the CD register?

To provide an auditable record of Schedule 2 CD movements.

What information should a Schedule 2 CD register supply entry contain?

Date of supply, patient details, authority to possess, collector details, ID information and quantity supplied.

When should CD register entries be made?

On the day of supply or at the earliest opportunity.

Should the CD register record what was intended or what actually happened?

What actually happened.

How should CD register mistakes be corrected?

With a traceable correction that preserves the audit trail.

What should never be used to correct a CD register?

Erasing, correction fluid or obscuring the original entry.

What is the purpose of running balances?

To detect errors, losses, missed entries and diversion.

Should balances be adjusted simply to make the register look correct?

No.

What is the difference between patient-returned CDs and pharmacy stock destruction?

Patient returns can be destroyed by the pharmacist, whereas Schedule 2 pharmacy stock destruction requires an authorised witness.

How should Schedule 2, 3 and 4.1 patient-returned CDs be destroyed?

By denaturing using an appropriate kit.

Should records of destroyed Schedule 2 patient returns be kept?

Yes, but not in the pharmacy CD register.

Can out-of-date Schedule 2 pharmacy stock be destroyed by a pharmacist alone?

No.

When should Schedule 2 stock be deducted from running balances?

Only after destruction has occurred and been correctly recorded.

What is the legal status of cannabis under the Misuse of Drugs Act?

Class B.

What schedule is cannabis usually placed in?

Schedule 1.

What are cannabis-based products for medicinal use (CBPMs)?

A defined legal category of cannabis medicines produced for medicinal use in humans.

What schedule are most CBPMs?

Schedule 2.

Is CBD itself a controlled drug?

No.

Why can CBD product legality vary?

Because some products may contain controlled cannabinoids such as THC.

What schedule is Sativex?

Schedule 4 Part I.

What schedule is Epidyolex?

Schedule 5.

Does Sativex require routine Schedule 2 CD register entries?

No.

What is the key point about cannabis-derived medicines?

They do not all belong to the same schedule.