Pharmaceutical legislation - Controlled drugs, record keeping + The Prescribing Cascade

What is a controlled drug?

Controlled drugs are listed in Schedules 1 to 5 of the Misuse of Drugs Regulations 2001 (MDR) - which categories the drugs based on therapeutic usefulness and potential harm caused by misuse

Schedule 1 Drugs

• Highest potential for misuse

• Not used in veterinary medicine are not used for medicinal purposes

Schedule 2 drugs

• Therapeutic value but addictive

• Strict controls on use 

Schedule 3 drugs 

• Some potential for abuse 

• Less strict control measures 

Schedule 4 drugs

• Divided int two parts

• Part 1 = contains benzodiazepines

• Part 2 = contains anabolic and androgenic steroids

• No additional controls

Schedule 5 drugs

• Very low strength substances so low risk of misuse

• No additional controls

Schiele 1 drugs - Examples

• Ecstasy

• Heroin 

• Cannabis 

Schedule 2 drugs - Examples 

• Morphine 

• Fentanyl

• Ketamine 

• Pethidine 

• Methadone 

Schedule 3 drugs - Examples

• Barbiturates

• Buprenorphine 

• Tramadol 

• Gabapentin 

Schedule 4 drugs - Examples

• Diazepam

• Anabolic steroids 

Schedule 5 drugs - Examples

• Codeine/Paracetamol 

POM-V and POM-VPS records kept for 5 years to include ..

• Date of receipt or supply

• Product details

• Batch number

• Quantity

• Name and address of supplier of recipient

• Name and address of prescriber if dispensing against a written prescription

The recent change to the VMR now also requires that where there is no written prescription .. 

The prescriber should record the reason for prescribing a product 

What is the prescribing cascade? 

• A provision in the Veterinary Medicines Regulations (VMR) that allows a veterinary surgeon to prescribe medicines to animals that would not otherwise be permitted 

• If a suitable medicine authorised in the UK does not exist → use the prescribing cascade (‘off-license’ / ‘off-label’) 

What is the purpose of the prescribing cascade?

To avoid causing unacceptable suffering and to treat the animal (welfare vs. economics)

The prescribing cascade - Food-producing animals

• Drug must be authorised for use in food-producing animals

• Have maximum reside limit (MRL)

• Withdrawal period (eggs, milk, meat and offal, fis meat)

The prescribing cascade - Horses

• Companion animal and food producing species

• Non-food horse → treated as a non-food animal under the cascade

• Food-producing horse → treated as a food-producing animal under the cascade

Imported medicines must be ..

• Authorised by the VMD

• Done so through the prescribing cascade

• Special Import Certificate (SIC), Special Treatment Certificate (STC)

• For individual use only

Exemption for Small Pet Animals (ESPA) 

• Formerly known as the Small Animal Exemption Scheme (SAES) 

• Aims to improve affability of veterinary products for these species ]Does not require a marketing authorisation 

• Does not include antibiotics and narcotic or psychotropic substances (anaesthetics) 

• Restricted to topical and oral administrations routes, and fish medicines administered via the water 

• Animals not intended for human consumption