Summary

  • All doctors can write a prescription for methadone which is prescribed in the same way as all other controlled drugs.

  • Doctors must notify the Home Office Drugs Branch if they attend anyone who they believe to be addicted to heroin, methadone or any one of a number of other drugs - even if they know that the patient has already been notified.

  • The Home Office Drugs Inspectorate receive reports from Chemist Inspecting Officers about pharmacy controlled drugs registers.

  • Chemist Inspecting Officers usually work as part of the drug squad and they may pass information about who has a methadone prescription to their colleagues.

  • Clients taking large quantities of methadone abroad are required to apply for an export licence.


Introduction
There are two main statutes that regulate the availability of drugs in the UK. The Medicines Act 1968 governs the manufacture and supply of medicinal products of all kinds, and its enforcement rarely affects the general public. It divides drugs into three catagories:

  • Prescription-only medicines
  • Pharmacy medicines
  • General sales list.

Methadone is a prescription-only medicine.

The second of the two statutes is the Misuse of Drugs Act 1971. One of its main functions is to prevent the unauthorised use of certain substances.

Drugs subject to this act are known as controlled drugs. Methadone is a controlled drug.

These two statutes cover many aspects of the production, prescribing, possession, supply, administration and disposal of methadone.

It is important that workers in contact with people using methadone are aware of the legal constraints on, and implications for, themselves and their clients.

The supply and possession of methadone
The manufacture of methadone and the law controlling it is covered in Section 3: Methadone manufacture and the preparations available.

Who can supply and prescribe methadone?
The prescribing of controlled drugs is limited to members of the medical professions. The system of specially licensing doctors to prescribe certain drugs to addicts covers diamorphine (heroin), cocaine and dipipanone (the analgesic ingredient of Diconal) but does not (and never has) extended to methadone.

Registered medical practitioners can prescribe methadone as treatment for pain relief or treatment of addiction.

The only exceptions to the above are doctors who have had their licence to prescribe controlled drugs revoked by the Home Secretary. Pharmacists can check whether or not a doctor has been prohibited from prescribing controlled drugs by telephoning the Home Office on:

  • 0171 273 3302

The prescription of all controlled drugs other than in the course of legitimate treatment is regarded as serious misconduct by the General Medical Council.79

Anyone found guilty of illegally supplying methadone to others (including clients who sell or give away their medication) can receive severe penalties under the Misuse of Drugs Act because methadone is a Class A drug.

Possession of methadone
The legal posession of methadone is restricted to:

  • Licenced manufacturers
  • Medical practitioners
  • Nurses or another person dispensing under the direction of a doctor
  • Pharmacists
  • Someone who has been legally prescribed methadone
  • Someone who has found it and is proceeding to a police station.

It is a crime for methadone to be supplied (sold, given, etc.) by anyone who is not authorised by law to do so and it is a crime to be in unauthorised possession of methadone.

Writing a methadone prescription
Controlled drugs should not be prescribed on a repeat prescription basis.

The prescription of methadone is carefully controlled. Only prescriptions which are legally written can be legally dispensed.

There is an example of how to write a methadone prescription on page 160.

The following strict requirements apply to prescriptions for methadone:

  • The prescriber must sign and date the prescription (a date stamp is legal, a computer-generated date is not legal)
  • The prescription must be written in indelible ink<
  • Unless it is an NHS or a local health authority prescription it must have the prescriber's address on it (all prescriptions should have the prescriber's telephone number so the pharmacist can ring if there is a problem).

Unless the prescriber has a handwriting exemption (see below) s/he must handwrite the following information on all methadone prescriptions:

  • Name and address of the client
  • Methadone dose, form and strength (e.g. methadone mixture DTF 1mg/mL)
  • Total number of milligrams (or millilitres) of methadone or the number of doses prescribed, in both words and figures.

If the prescription is to be dispensed in instalments the doctor must use the correct pad (see below) and specify:

  • The total quantity prescribed, as above
  • The amount to be supplied per instalment
  • The intervals at which the instalments are to be dispensed (bearing in mind days when the pharmacy may be closed such as weekends and public holidays).

If the prescriber has a handwriting exemption this information can be produced in another way but it must appear on the prescription.

Which prescription pad?

Single collection
In general practice a methadone prescription with a single collection date should be written on a standard white FP10 form. In hospital out-patients an orange FP10 (HP) should be used.

Multiple collections
Multiple collections from a community pharmacy, prescribed by a GP, must be on the blue FP10 (MDA) in England, Wales or Northern Ireland and on a GP10 in Scotland.

Hospital doctors in England, Wales or Northern Ireland should use form FP10(HP)(ad) and in Scotland form HPB(A) should be used.

Handwriting exemptions

The Home Office can give handwriting exemptions to doctors who issue more than 10 controlled drug prescriptions to addicts per week.

This means that prescriptions can be written by key-workers, typed, produced by computer or using a rubber stamp. The doctor need only sign and date them (see above). Prescriptions produced thus must still contain all the information as listed above.

Doctors who need a Home Office handwriting exemption can receive an application form from:

The Licensing Section
Home Office
50 Queen Anne's Gate
London SW1 9AT
Tel: 0171 273 3000 ext. 2446

Dispensing and collection of methadone
Methadone is a Schedule 2 controlled drug. Pharmacists are among those who have a general authorisation to procure, possess and supply methadone.

It is a professional requirement for pharmacists to supply methadone in bottles with 'child-resistant' caps. These bottles should be clearly labelled with the quantity of methadone they contain (in case the contents are ingested by accident or someone overdoses). All other labelling requirements for medicines apply as usual.

Receipt of methadone at a pharmacy
Methadone must be received into pharmacy stock by a registered pharmacist. On receipt the quantity supplied should be checked and an entry made in the purchases section of the controlled drugs register. The methadone should then be placed in the controlled drugs cabinet.

Storage of methadone in the pharmacy
Methadone must be stored in a locked safe, cabinet or 'room which is so constructed and maintained as to prevent unauthorised access'. When methadone is removed from storage it must remain under the direct personal supervision of a pharmacist.

Supply of methadone from a pharmacy
All methadone supplies must be recorded on dispensing in accordance with the Misuse of Drugs Act legislation.

For a controlled drug to be supplied to an individual they must be in possession of a prescription.

Before dispensing the pharmacist has to be satisfied that the:

  • Prescription is written correctly (see above)
  • Prescriber's address as written on the prescription is within the UK
  • Prescriber's signature is known to the pharmacist or has been checked and found to be legitimate
  • Date of supply is after the date specified on the prescription
  • Date of supply is within 13 weeks of the date on the prescription.

The prescription must be dated at the time of dispensing. It must then be retained by the pharmacist for 2 years (except in the case of NHS and LHA prescriptions).80

Collecting methadone
On-site/in-patient administration of methadone and take-out methadone dispensing can be done only in accordance with an individual medical prescription. Methadone prescribed for an individual should only be supplied to that person.

Clients who are unable to attend to collect their own methadone and who wish another person to collect the dose/s on their behalf should provide proof that this is their intention. The same is true for collecting the paper prescription from the prescribing service.

These safeguards help protect the confidentiality of the client regarding their treatment, and prevent theft by people posing as friends and collecting methadone which they have no intention of passing on to the person to whom it belongs.

Collection in instalments
Prescriptions to be supplied in instalments must be dispensed in accordance with directions. The first instalment must be dispensed within 13 weeks of prescribing. The pharmacist must date the prescription at the time of each dispensation, and make the appropriate entry in the controlled drugs register.

The NHS provides special prescription forms for daily supplies of methadone to be dispensed to drug users: see above.

Requests for missed or late collections
Clients who collect their methadone from a community pharmacist sometimes come in a day early or a day late for their methadone. Strictly speaking they should receive no methadone. In practice some pharmacists will dispense a day late, omitting the dose for the day they did not collect, although this is not in accordance with the law.

However requests to collect methadone early (whatever the reason) should be referred back to the drug service or prescribing doctor. Such requests are often an indication that either things are not going well and the client is using more than the prescribed daily dose of methadone and is able to miss doses because they are using other substances, or that the pick-up days are unsuitable because of work or other committments.

Methadone in hospitals

Destruction of methadone at a ward or clinic
Methadone stocks not required on the ward can be returned to the pharmacy for destruction. A methadone dose specifically prepared for a patient to take home should also be returned to the pharmacy and destroyed if not collected by the patient.

Destruction of methadone at the pharmacy
Any methadone which is recorded as part of the pharmacy stock and needs to be destroyed (for instance if it has passed its expiry date or if there is no longer a need to stock methadone), must be done so only in the presence of an 'authorised person'.

However if methadone that has been dispensed is returned to the pharmacy it can be destroyed by a pharmacist without the presence of an authorised person, and should not be re-entered into the pharmacy stock.

Notification to the Home Office

When and whom doctors should notify
The Misuse of Drugs Act 1973 requires doctors to notify the Chief Medical Officer at the Home Office within 7 days if they attend a patient who they consider to be, or have reasonable grounds to suspect is, addicted to any of the controlled drugs listed below:

  • Cocaine
  • Palfium
  • Diamorphine (heroin)
  • Dipipanone (Diconal)
  • Hydrocodone
  • Hydromorphone
  • Levorphanol
  • Methadone
  • Morphine
  • Opium
  • Oxycodone
  • Pethidine
  • Phenazocine
  • Piritamide.

This includes patients who:

  • Are temporary residents
  • Are referred by another doctor/service
  • Are known to be in receipt of treatment from another doctor
  • Have recently been in receipt of treatment from another doctor
  • Are known to have been recently notified to the Home Office
  • The doctor decides not to treat.

What doctors should notify
There are forms available from your local FHSA/Health Commission but notifications can be made by letter and should contain the following information about the patient:

  • Name
  • Address
  • Gender
  • Date of birth
  • NHS number (if known)
  • Date of attendance
  • Drugs concerned
  • Whether or not the patient injects
  • What, if anything, was prescribed.

They should be sent to:

The Drugs Branch
Home Office
50 Queen Anne's Gate
London SW1 9AT

Confidentiality
The information is confidentially stored on the Addicts Index which is only used by doctors to verify the history given by new patients and for research purposes.

Using the Addicts Index
Doctors can check the medical history of patients who present to them for treatment of a drug problem during office hours by phoning the Addicts Index direct on: 0171 273 2213.

Outside office hours an answering machine will take messages. Callers will be phoned back and given details of doctors who had previously notified the patient.

The 'registered addict'
The status of having been notified to the Home Office is often termed as being a 'registered addict', but there is, in fact, no such status.

Being notified to the Addicts Index is often much overrated or feared by drug users. In fact notification confers no rights to treatment nor loss of civil liberties and is simply a system to prevent multiple prescribing, to facilitate research and to inform funding decisions. There has never been a confirmed case of information from the register being passed to the police, visa authorities or anyone other than doctors enquiring about their patients.

Informing the users of this may help reduce the anxiety associated with notification.

The police may find out that people are being treated with methadone but this will be via the Pharmacy Inspecting Officer system - see below.

Regional databases
Alongside the notification system there is also the regional database system, which exists in most areas. This is a non-compulsory system which counts the number of drug users presenting to services and gives a brief outline of their problems. It is used for gathering statistical information and informing purchasing decisions. This information is also stored confidentially and personal information is not passed to any third party.

Driving

Driving licence
The Road Traffic Act requires holders of, or applicants for, a driving licence to inform the Driver Vehicle Licensing Authority (DVLA) of '...any disability likely to affect safe driving'. DVLA considers drug use, including the use of prescribed drugs, to be a 'disability' in this context.

This responsibility lies with the holder or applicant, not the prescribing doctor or drug service.

DVLA will not issue a group 2 (HGV/PSV) licence to anyone receiving methadone treatment.

If a client with a group 1 driving licence informs DVLA that they are receiving an oral methadone prescription they are then required to have a short (free) independent medical examination. This includes a urine screen for drugs. If there are only methadone metabolites in the urine a licence is normally issued for one year. They will be called back for another medical every year until 3 years after methadone treatment has finished.

If a client informs DVLA that they are receiving injectable methadone on prescription, the licence may be withdrawn, although a letter from a consultant psychiatrist confirming that the client experiences low levels of sedation can result in a decision to treat the prescription of injectable methadone in the same way as oral methadone.

On re-application the client will have to undergo a medical including a urine screen for drugs. They will be called back for another medical every year until 3 years after methadone treatment has finished.

If the urine screen carried out for the DVLA medical shows positive for cannabis they will withdraw the licence for 6 months. If it shows positive for any other drug they will withdraw the licence for 12 months. There will be another medical on re-application and every year for the first 3 years after the licence has been returned.

Driving under the influence of methadone
It is also an offence to be in charge of a vehicle if 'unfit to drive through drink or drugs'. A client taking methadone would not automatically be considered by the courts to be unfit to drive and the onus of proof is on the prosecution to prove that s/he was unfit to drive because of the methadone.

Insurance companies may also consider a methadone prescription as an additional risk about which they should have been informed, and may contest claims from drivers who are discovered to have been receiving prescribed methadone at the time of an accident.

Whether or not practitioners should take the step of breaching confidence and informing DVLA without their client's consent, if they are concerned about a client's ability to drive or if the client is driving passenger or heavy goods vehicles, is a complex ethical issue.

Guidance should be sought from professional bodies in terms of professional responsibility and from the practitioner's line manager for guidance in terms of their employment. The correct course of action will depend on the balance of exercising the duty of care for the client and the community - weighing the relative risks of accident and injury with the benefits in terms of client and community safety of continued client contact.

In cases where ability to drive under the influence of methadone is an issue the problem of confidentiality can be easily avoided by encouraging the client to either contact DVLA themselves or giving the practitioner permission to do so.

The Home Office Drugs Inspectorate
The primary function of the Inspectorate - together with the Licensing Section - is to control the manufacture and distribution of controlled drugs. The controls and the drugs to which they apply are laid down in the Misuse of Drugs Act 1971 and dependant regulations.

The Inspectorate:

  • Makes recommendations on the suitability of applicants for licences to manufacture and store controlled drugs
  • Determines the precautions which must be taken for safe custody of controlled drugs in the possession of a licensee
  • Inspects security, documentation and record keeping
  • Investigates irresponsible prescribing of controlled drugs by doctors.

Irresponsible prescribing may lead to a doctor's prescribing practice being referred to a Misuse of Drugs Tribunal which can recommend to the Home Secretary that he use his power to ban the doctor from prescribing controlled drugs. Irresponsible prescribing usually constitutes prescribing high doses of inappropriate drugs to large numbers of people despite cautioning from the Drugs Inspectorate, and not the legitimate prescription of methadone, with appropriate support, to heroin users.

In addition to its inspectorial and investigative functions the Inspectorate also acts as the agency within the Home Office which liaises between central government and other bodies at a regional and local level concerned with drug misuse.

Pharmacy inspecting officers
Retail chemists' controlled drugs registers are inspected by the police for the Home Office Drugs Inspectorate. The person who does this has the title of the 'Chemists Inspecting Officer'. It is as a result of this that cases of irresponsible prescribing would normally come to light.

However as the Chemists Inspecting Officers usually work as part of the drug squad and have no obligation to keep the information they have gained confidential, it is through this route that local police forces often find out that people have methadone prescriptions.

Patients going abroad
If a client is travelling abroad and is carrying a supply of methadone they will require a Home Office licence if they are taking more than 15 days' supply or 500 mg of methadone.

Export licences are issued by:

The Drugs Licensing Section
Home Office
Room 230
50 Queen Anne's Gate
London SW1H 9AT

There is no standard application form. Application must be made by the person who wants to take the methadone out of the country.

They should write to the Home Office at the address above, enclosing a letter from their prescribing doctor, giving the following details:

  • Name and address
  • Quantities of drugs to be carried
  • Strength and form in which the drugs will be dispensed
  • Date of travel from the United Kingdom
  • Date of return.

The Licence is required under the Misuse of Drugs Act to facilitate passage through UK Customs Control. However, clients should be aware that it has no legal status outside the UK. To find out whether methadone can be taken into the country/countries the client is visiting they should contact the relevant Embassy or Consulate well before departure.

If a client is planning to go abroad for an extended period and wishes to take a supply of methadone it may be possible to arrange for a clinic to prescribe in the country concerned. The Embassy or Consulate may be able to advise if this is possible and give the names of clinics.

A Home Office licence is not necessary for amounts under 500mg provided the client is not carrying more than 14 days' supply, although it is advisable to carry a 'to whom it may concern' letter from the prescribing doctor confirming that the client is in possession of the methadone for legitimate medical purposes.