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
Who can supply and prescribe 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:
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
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
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:
Unless the prescriber has a handwriting exemption (see below) s/he must handwrite the following information on all methadone prescriptions:
If the prescription is to be dispensed in instalments the doctor must use the correct pad (see below) and specify:
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?
Hospital doctors in England, Wales or Northern Ireland should use form FP10(HP)(ad) and in Scotland form HPB(A) should be used.
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
Dispensing and collection of 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
Storage of methadone in the pharmacy
Supply of methadone from a pharmacy
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:
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
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
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
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
Destruction of methadone at the pharmacy
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
This includes patients who:
What doctors should notify
They should be sent to:
The Drugs Branch
Using the Addicts Index
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'
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.
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
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
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
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
Export licences are issued by:
The Drugs Licensing Section
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:
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.