Medicines Updates

Medical Director’s Bulletin No 2

Medicines update – Reclassification of Tramadol

Wilderness Medical Training advocate the use of tramadol (a synthetic opioid) in an emergency situation in an overseas wilderness setting for the management of severe pain.

The UK Home Office announced that as of 10th June 2014, tramadol would be classified as a Class C controlled drug and placed in Schedule 3 (from Schedule 5) of the 2001 regulations on misuse of drugs, following a spate of deaths linked to ‘recreational’ use. This decision follows a recommendation by the Advisory Council on the Misuse of Drugs (ACMD). There is however a desire to ensure that those who require it will be able to get it on prescription.

There has been a prolonged consultation period prior to this decision being confirmed.

The classification of drugs is discussed below followed by the guidance for subsequent use by health care professionals and explorers trained by WMT.

Class of drug

Lay people often understand the forensic classification of drugs. These are outlined directly below. However, more relevant to those involved in prescribing and dispensing medications is the scheduling of drugs. It is the change in scheduling that should be understood by all who prescribe, dispense and most relevant to WMT explorers, carry tramadol.

Classes of Controlled Drugs

Forensic classification

The Misuse of Drugs Act 1971 prohibits certain activities in relation to ‘Controlled Drugs’, in particular their manufacture, supply and possession. The grading of such drugs broadly reflect the harm caused if misused.

Class A
Cocaine, diamorphine, LSD, MDMA, morphine, opium, pethidine
Class B substances when prepared for injection

Class B
Oral amphetamines, cannabis, barbiturates, codeine

Class C
Benzodiazepines, anabolic steroids, tramadol

Scheduling of drugs (including Controlled Drugs that are only found in Schedules 1-3)

Medical classification

The Misuse of Drugs Regulations 2001 define the classes of person who are authorised to supply and possess controlled drugs whilst acting in their professional capacities. In the regulations, drugs are divided into five schedules each specifying the requirements governing such activities as import, export, production, supply, possession, prescribing and record keeping that apply to them.

Schedule 1

Drugs belonging to this schedule are thought to have no therapeutic value and therefore cannot be lawfully possessed or prescribed. These include LSD, MDMA (ecstasy) and cannabis. Schedule 1 drugs may be used for the purposes of research but a Home Office licence is required.

Schedule 2 & 3

The drugs in these schedules can be prescribed and therefore legally possessed and supplied by pharmacists and doctors. They can also be possessed lawfully by anyone who has a prescription. It is an offence contrary to the 1971 Act to possess any drug belonging to Schedule 2 or 3 without prescription or lawful authority. Examples of Schedule 2 drugs are methadone and diamorphine (heroin). Schedule 3 drugs include subutex, tramadol and most of the barbiturate family.

The difference between Schedule 2 and Schedule 3 drugs is limited to the application of the 2001 Regulations concerning record keeping and storage requirements in respect of Schedule 2 drugs.

Schedule 4 (i) & (ii)

Schedule 4 was divided into two parts by the 2001 Regulations [as amended by the Misuse of Drugs (Amendment No. 2) Regulations 2012]

Schedule 4(i) controls most of the benzodiazepines. Schedule 4(i) drugs can only be lawfully possessed under prescription. Otherwise, possession is an offence under the 1971 Act.

Schedule 4(ii) drugs can be possessed as long as they are clearly for personal use. Drugs in this schedule can also be imported or exported for personal use where a person himself carries out that importation or exportation. The most common example of a schedule 4(ii) drug is steroids.

Schedule 5

Schedule 5 drugs are sold over the counter and can be legally possessed without a prescription.

What does the change in Scheduling of tramadol mean for WMT alumni?

Doctors

A prescription for tramadol now needs to be handwritten in words and figures. The prescription must also have the patient’s name, address and the prescriber’s name. It must be dated and signed and specify the preparation of tramadol, it’s form and total quantity (in words and figures). Only a maximum of 28 days can be supplied. There is no requirement to enter the drug in a Controlled Drugs register.

If the tramadol supplied expires, ensure that it is given to a pharmacist for safe disposal.

Allied Health Professionals and Explorers

Tramadol can be obtained from Nomad Medical on completion of FFH (oral preparation) or FFH2 (oral and intramuscular preparations). Small quantities will be dispensed (10 tablets or 5 vials) for the treatment of severe pain in an overseas environment in an emergency setting where access to medical care is not immediately possible.

Due to the Controlled Drugs prescription regulations, there will be a small extra administration charge levied by Nomad to process the prescription for tramadol. However, Nomad will dispense tramadol along with a letter for export purposes (there is no legal requirement for this but it remains best practice).

It is worth reiterating that with the change of tramadol to a Schedule 3 drug, it is imperative that the drug remains with the person to whom it is prescribed (allied health professionals without prescribing rights and explorers must NOT dispense tramadol or any other prescription only medications in the UK).

If the drug expires, please ensure that it is safely disposed via a pharmacist.

Dr Harvey Pynn
24 June 2014