What are controlled drugs and why are they controlled?

Some medicines are subject to further legislation under the Misuse of Drugs Act (1971) and the Misuse of Drugs Regulations [Northern Ireland] (2002). Medicines that are included in the Misuse of Drugs Act are called Controlled Drugs (CD). The aim of this act was to control “dangerous or otherwise harmful drugs” as they are more prone to abuse or addiction.

What drugs are controlled?

Common examples of CDs are opiate analgesics such as morphine, fentanyl and methadone and amphetamine-type drugs such as methylphenidate.

CDs are further classified into 5 schedules with the strictest requirements and dangerous drugs in Schedule 1 and the least dangerous drugs in Schedule 5.

The 5 Schedules of CDs

Schedule 1 (CD Lic)

• Mostly illegal drugs e.g., ecstasy and LSD, which have limited, if any, therapeutic use.

• Pharmacists shouldn’t be in possession of these drugs unless taking them into custody to destroy them, or to hand them over to the police.

• A license is needed from these drugs Home Office to possess, supply or produce these drugs.

Schedule 2 (CD)

• Includes opiates, amphetamines, the barbiturate quinalbarbitone (secobarbital) and ketamine.

• Pharmacists can only supply these to patients against a valid prescription written by an appropriate prescriber.

• Subject to safe custody requirements and should be kept in a locked medicines cupboard or safe. Time-delay safes deter theft from less secure safes and cabinets.

• A record must be made when these medicines are obtained (purchased) or supplied (to a patient or doctor etc.) in the CD register.

• Schedule 2 or 3 drugs must also be endorsed with the total quantity of drug dispensed, the date and pharmacist initials written on the prescription.

Schedule 3 (CD No Reg)

• A smaller schedule than Schedule 2 containing drugs which are considered less likely to be abused.

• These do not require entry into the CD register.

• Currently, all drugs in this schedule are exempt from safe custody requirements, except temazepam, flunitrazepam, buprenorphine and diethylpropion.

• In 2019 gabapentin and pregabalin were added to this schedule (and these are also exempt from safe custody requirements).

Schedule 4 (CD Benz and CD Anab)

• Two parts to this schedule - CD Benz (Part 1) which contains most of the benzodiazepines e.g., diazepam, nitrazepam; CD Anab (Part 2) which contains the anabolic and androgenic steroids e.g., testosterone, the stimulant clenbuterol and some growth hormones.

• Not subject to safe custody, CD prescription requirements or CD register entries.

• Prescriptions only valid for 28 days.

Schedule 5 (CD Inv)

• Preparations of CDs at low strengths in medicinal products aren’t subject to the controls in the Misuse of Drugs Acts as they are less likely to be abused, such as lower dose or strength preparations of morphine, codeine, dihydrocodeine, pholcodine, dextropropoxyphene or diphenoxylate.

• When these medicines are obtained or supplied, the invoice must be kept for 2 years.

• Most of these are CD Inv POM but some are CD Inv P medicines and can be purchased OTC e.g., products containing codeine or dihydrocodeine.

Extra requirements for CD prescription

• The total quantity of the preparation or the number of dosage units must be written in both words and figures e.g., 60 (sixty) tablets.

• Dentist prescriptions should state “For dental treatment only.”

• The dose (NOTE: “as directed” is insufficient but “one as directed” is acceptable).

• It is also good practice to get the recipient of the prescription to sign the back of the prescription when collecting it from the pharmacy.

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