Controlled Drugs
Definition: A controlled drug is defined as any substance which due to its potential for misuse and or abuse, is listed in the schedule to the Misuse of Drugs Acts 1977 and 1984.
A licence is needed to legally permit importing, exporting, manufacturing, or holding controlled drugs.
Our role is to review each application received for a controlled drug license. We may carry out an inspection as part of the application process.
We evaluate applications from various sectors of the pharma-related industry such as manufacturers, distributors, and academic institutions. We assess their compliance with security, storage, and documentation requirements. Each licence is issued by the Department of health.
Precursor Chemicals
Precursor chemicals are used in the manufacture of licensed medicines, certain food stuffs and for other scientific or laboratory uses. These are raw chemicals which if procured by illegal sources could be used for illicit purposes.
Our role is to regulate the movement of precursor chemicals. We assess, register and approve import or export authorisations for such chemicals.
The HPRA’s role also extends to inspecting, as required, these products when they come into Ireland or when they are exported from the country.
Legal controls
Stricter legal controls apply to controlled medicines to prevent them:
-
Being misused
- Being obtained illegally
- Causing harm
- Stored
- Produced
- Supplied
- Prescribed
Controlled medicines are classified (by law) based on their benefit when used in medical treatment and their harm if misused.
The Misuse of Drugs Regulations include five schedules that classify all controlled medicines and drugs. Schedule 1 has the highest level of control, but drugs in this groups are virtually never used as medicines. Schedule 5 has a much lower level of control.
List of Controlled Drugs
Amphetamines (including dexamphetamine)
Amphetamines are class B, schedule 2 drugs. It is illegal to possess them without a prescription or to supply or produce them without a licence. If prepared for injection they become class A substances.
Anabolic steroids
Anabolic steroids are class C, schedule 4drugs. Unauthorised supply or production is an offence and carries a maximum of 14 years’ imprisonment and a fine.
Benzodiazepines (including diazepam, flunitrazepam and temazepam)
Benzodiazepines are class C drugs.
Possession carries a maximum sentence of 2 years’ imprisonment and a fine. Supply or production carries a maximum sentence of 14 years’ imprisonment and a fine.
Buprenorphine (including Subutex)
Buprenorphine is a class C, schedule 3 drug.Illegal supply or production carries a maximum sentence of 14 years’ imprisonment and a fine.
BZP (and other piperazines)
Piperazines (including BZP and TFMPP) are Class C, Schedule 1 drugs.. Possession with intent to supply, trafficking offences and production of Class C drugs carry a maximum sentence of 14 years imprisonment and a fine.
Cannabis
Cannabis is a class B, schedule 1 drug. Possession carries a maximum sentence of 5 years’ imprisonment and a fine. Trafficking offences carry a maximum sentence of 14 years’ imprisonment and a fine.
Cannabis Warnings: A person found in possession of cannabis for the first time can receive a cannabis warning if there are no aggravating factors (please see below). Where a police officer decides to proceed with a cannabis warning the individual should be warned that:
a record of the investigation will be made at the police station; the offence of possession will be recorded against them, for statistical purposes, as a detected crime; this procedure does not constitute a criminal record.
Cocaine (including crack cocaine)
Cocaine is a class A, schedule 2 drug. Possession without a prescription is illegal. It is illegal to supply or produce cocaine.Possession carries a maximum sentence of 7 years’ imprisonment and a fine. Supply or production carries a maximum sentence of life imprisonment and a fine.
Codeine
Codeine is a class B, schedule 2 drug. If prepared for injection it becomes a class A substance.
Possession of class A drugs carries a maximum sentence of 7 years’ imprisonment and/a fine. Trafficking offences carry a maximum sentence of life imprisonment and a fine.
DMT
DMT (N,N-dimethyltryptamine) is a Class A, Schedule 1 drug.Possession of Class A drugs carries a maximum sentence of 7 years’ imprisonment and a fine.
Ecstasy
Ecstasy is a class A, schedule 1 drug.
Possession carries a maximum sentence of 7 years’ imprisonment and/a fine.
Hallucinogenic mushrooms containing psilocin
Any fungus which contains psilocin is a class A, schedule 1 drug.
Possession carries a maximum of 7 years imprisonment and/or fine.
Heroin (diamorphine)
Heroin is a class A, schedule 2 drugPossession carries a maximum sentence of 7 years’ imprisonment and a fine.
Khat
Khat is a class C, schedule 1 drug. Possession carries a maximum sentence of 2 years’ imprisonment and a fine. Trafficking offences carry a maximum sentence of 14 years’ imprisonment and a fine.
Ketamine
Ketamine is a class B, schedule 4 drug. It Possession carries a maximum sentence of 5 years’ imprisonment and/or fine. Trafficking offences carry a maximum sentence of 14 years’ imprisonment and a fine.
Mephedrone
Mephedrone is a class B drug. Possession of the drug could result in up to 5 years' imprisonment and a fine, supply offences in up to 14 years' imprisonment and a fine.
Methadone
Methadone is a class A, schedule 2 drug.Possession carries a maximum sentence of 7 years’ imprisonment and a fine.
Methoxetamine
Methoxetamine is a Class B, Schedule 1 drug.Possession of Class B drugs carry a maximum sentence of 5 years’ imprisonment and a fine
Methylamphetamine
This is a class A, schedule 2 drug. Possession carries a maximum sentence of 7 years’ imprisonment and/or fine.
Methylone
Methylone is a class B drug. Possession of the drug could result in up to 5 years' imprisonment, supply offences in up to 14 years' imprisonment.
Morphine
Morphine is a class A, schedule 2 drug.Possession carries a maximum sentence of 7 years’ imprisonment and a fine.
NRG-1, NRG-3, Naphyrone
Naphyrone (and the related drugs NRG-1 and NRG-3) is a Class B, Schedule 1 drug. Possession of Class B drugs carry a maximum sentence of 5 years’ imprisonment and a fine. Possession with intent to supply, trafficking offences and production of Class B drugs carry a maximum sentence of 14 year’s imprisonment and a fine.
Opium
This is a class A drug. In its raw form it is a schedule 1 drug but in a medicinal form it is schedule 2. It is an offence to possess, supply or produce.
Possession carries a maximum sentence of 7 years’ imprisonment and/a fine.
PMMA/PMA
Para-methoxyamphetamine (PMA) and para-methoxymethamphetamine (PMMA) are Class A, Schedule 1 drugs. Possession of Class A drugs carries a maximum sentence of 7 years’ imprisonment and a fine.
Subutex
Subutex is a Class C, Schedule 3 drug. Possession of Class C drugs carries a maximum sentence of 2 years’ imprisonment and a fine. Possession with intent to supply, trafficking offences and production of Class C drugs carry a maximum sentence of 14 years imprisonment and a fine.
5-MeO Group
5-MeO-DMT (not to be confused with DMT) is a Class A, Schedule 1 drug. It is illegal to possess, supply and produce.
How are controlled substances classified?
Controlled medications are broken down into more specific categories, which have different restrictions on how and when they can be filled or refilled.
Schedule 1 (Controlled Drug licence)
Have no recognised medicinal use and include cannabis, coca leaf, lysergic acid diethylamide (LSD) and mescaline.
Production, possession and supply of these drugs are limited to research or other special purposes.
Practitioners and pharmacists may not lawfully possess Schedule 1 drugs except under licence.
Eg. acetyl methadol, allyprodine, acetylmethadol, bufotenine, dextromoramide, diethyltryptamine, dimethyltryptamine–DMT, etorphine, heroin, ibogaine,ketobemidone, LSD–N,N-diethyl-D-lysergamide or lysergic acid diethylamide, marijuana, mescaline, PCP–phencyclidine,peyote, phenadoxone, phenampromide, racomoramide, tetrahydrocannibol
Schedule 2 (Controlled Drugs)
Includes diamorphine (heroin), morphine, remifentanil, pethidine, secobarbital, glutethimide, amfetamine, and cocaine.
Are subject to safe custody requirements and so must be stored in a locked receptacle, usually in an appropriate CD cabinet or approved safe, which can only be opened by the person in lawful possession of the CD or a person authorised by that person.
A licence is required to import or export drugs in Schedule 2.
The drug may be administered to a patient by a doctor or dentist, or by any person acting in accordance with the directions of a doctor or dentist.
A register must be kept for Schedule 2 CDs and this register must comply with the relevant regulations.
The destruction of CDs in Schedule 2 must be appropriately authorised and the person witnessing the destruction must be authorised to do so.
Eg. narcotics anileridine, cocaine, codeine, diphenoxylate, diprenorphine,etorphine HCl, ethymorphine, hydrocordone, hydromorphone, levorphanol, meperidine, methadone, morphine,oxymorphone, poppy straw concentrates, powdered opium, raw opium, thebaine and non-narcotics–amphetamine,amobarbital, methaqualone, methamphetamine, methaqualone, pentobarbital, percodan, phencyclidine, phenmetrazine,secobarbital
Schedule 3 (Controlled Drugs - no register)
Includes a small number of minor stimulant drugs and other drugs which are less likely to be misused than the drugs in Schedule 2.
Examples are the barbiturates (except secobarbital, now Schedule 2), buprenorphine, diethylpropion, mazindol, meprobamate, midazolam, pentazocine, phentermine, and temazepam.
The government has now placed tramadol in Schedule 3 to the Misuse of Drugs Regulations 2001 but with exemption from the safe custody requirements.[2]
Are exempt from safe custody requirements and can be stored on the open dispensary shelf except for temazepam, buprenorphine and diethylpropion, which must be stored in a locked CD receptacle.
Are subject to the same special handwriting requirements as Schedule 2 CDs.
There is no legal requirement to record transactions in a CD register.
The requirements relating to destruction do not apply unless the CDs are manufactured by the individual.
Invoices must be retained for a minimum of two years.
Schedule 4
Are exempt from safe custody requirements, with destruction requirements only applying to importers, exporters and manufacturers.
Specific CD prescription-writing requirements do not apply.
CD registers do not need to be kept, although records should be kept if such CDs are produced, or if a licensed person imports or exports such drugs:
Part 1: benzodiazepines (except temazepam and midazolam, which are in Schedule 3) and zolpidem, which are subject to minimal control:
Includes most of the benzodiazepines, plus eight other substances including fencamfamin and mesocarb.
Possession is an offence without an appropriate prescription. Possession by practitioners and pharmacists acting in their professional capacities is authorised.
Are subject to full import and export control.
Part 2 includes androgenic and anabolic steroids, clenbuterol, human chorionic gonadotrophin (hCG), non-human chorionic gonadotrophin, somatotropin, somatrem, and somatropin:
Includes most of the anabolic and androgenic steroids such as testosterone, together with clenbuterol (adrenoreceptor stimulant) and growth hormones.
There is no restriction on the possession when it is part of a medicinal product.
A Home Office licence is required for the importation and exportation of substances unless the substance is in the form of a medicinal product and is for self-administration by a person.
Schedule 5 (Controlled Drug - invoice)
Includes preparations of certain controlled drugs (eg, codeine, pholcodine, morphine) which are exempt from full control when present in medicinal products of low strengths, as their risk of misuse is reduced.
No restriction on the import, export, possession, administration or destruction of these preparations and safe custody regulations do not apply.
A practitioner, pharmacist or a person holding an appropriate licence may manufacture or compound any CD in Schedule 5.
Therefore exempt from virtually all CD requirements other than that invoices must be kept for a minimum of two years.
Standard operating procedures (SOP)
Regulations made under the Health Act 2006 require each healthcare organisation to appoint an Accountable Officer, responsible for the safe and effective use of CDs in their organisation. The Regulations also introduce standard operating procedures (SOPs) for the use and management of CDs. GP practices will need to have an appropriate process in place to agree and adopt SOPs for their use.
An SOP is a document that describes the responsibilities and the procedures, including audit, necessary to manage CDs safely and accountably. The SOPs must include:
- Ordering and receipt of CDs.
- Assigning responsibilities.
- Where the CDs are stored.
- Who has access to the CDs.
- Security in the storage and transportation of CDs as required by misuse of drugs legislation.
- Disposal and destruction of CDs.
- The person who is to be alerted if complications arise.
- Record keeping, including:
- Maintaining relevant CD registers under misuse of drugs legislation
- Maintaining a record of the CDs specified in Schedule 2 to the Misuse of Drugs Regulations 2001 that have been returned by patients
- The practice SOP should also include:
- Responsibilities within the practice team.
- Validation by clinical commissioning group (CCG) and date.
- Review period - eg, one, two or three years.
- Lead author and named people contributing to the SOP.
- Form for pharmacist to take record of Control drugs:
Who can prescribe controlled medicines?
Doctors and dentists can prescribe all controlled medicines to treat illness or injury. However, doctors must hold a licence from the Home Office to prescribe controlled medicines to treat addiction.
Prescriptions for Controlled Drugs
The amendments to the Misuse of Drugs Regulations 2001 that came into force in November 2005 removed the requirement that CD prescriptions should be written in the prescriber's own handwriting. This means that CD prescriptions can be typewritten, handwritten or computer printed. Only the signature of the prescriber has to be handwritten.
NHS prescription form
FP10 prescription forms now include a box on the back of the prescription where the signature of the patient or other person collecting a Schedule 2 or 3 CD must be recorded.
Form FP10MDA-S is used for prescribing CDs (mainly methadone) to addicts. It is twice the size of the standard FP10 because it contains space for the pharmacist to record each time an instalment is supplied.
Private prescription form
A special form (FP10PCD) has been introduced for any private prescription of schedule 2 and 3 CDs which will be dispensed in the community.
The prescriber should obtain the patient's NHS number if possible and enter this number on the prescription form.
Prescribing in instalments
Some CDs can be dispensed to substance misusers in instalments, providing they are prescribed using specific NHS prescription forms.
The total quantity of CD that will provide treatment for a period not exceeding 14 days.
The quantity to be supplied in each instalment.
Current legislation does not allow Schedule 2 and 3 CDs to be prescribed as repeat prescriptions (ie to be part of the repeat prescribing or dispensing system)
Role of Pharmacist in managing control drugs:Ordering, possessing and supplying Controlled Drugs
Doctors, dentists and pharmacists are authorised under the Misuse of Drugs Regulations 2001 to possess, supply and compound CDs in Schedules 2, 3, 4 and 5. They may only supply CDs to those who may lawfully possess them, including patients for whom a drug is prescribed.
Paramedics have more recently been authorised to possess and administer controlled drugs.
Practitioners must not use patient-specific CD prescriptions to replace or top up their bags or practice stock, even if the stock was used for that patient initially.
Practitioners may obtain Schedule 2 and 3 CDs from pharmacies or wholesalers for practice use or stock upon the production of a written requisition.The requisitions must be:
- Signed by the prescriber.
- State the prescriber's name and address, and their profession or occupation.
- Specify the total quantity of the drug (this does not have to be in words and figures).
- Specify the purpose for which it is required - eg, for practice use.
- Suppliers must keep all requisitions for a minimum of two years. A requisition is not required before supplying or obtaining Schedule 4 or 5 CDs.
- A practitioner who requires a Schedule 2 or 3 CD urgently and who is unable to supply a signed order can request the drugs to be supplied in an emergency. The practitioner may be supplied with the CD provided he or she gives an undertaking to supply a written, signed requisition within 24 hours. Failure to do this is a criminal offence on the part of the practitioner.
- It is the responsibility of the pharmacist or doctor, when receiving a supply of CDs from the wholesaler, to ensure that the correct item is delivered and that all appropriate entries are made in the CD register on the day of supply, or the day following the day of supply.
- There is now a requirement for persons asked to supply Schedule 2 CDs on prescription to seek to establish whether the person collecting the drug is the patient, the patient's representative or a healthcare professional acting in his/her professional capacity on behalf of the patient.
- Where the person is the patient or the patient's representative (eg, a friend, or a neighbour) the dispenser:
- May request evidence of that person's identity; and
- May refuse to supply the drug if he/she is not satisfied as to the identity of that person.
- Where the person collecting the prescription is a healthcare professional acting in his/her professional capacity on behalf of the patient, the dispenser:
- Must obtain that person's name and address.
- Must, unless he/she is acquainted with that person, request evidence of that person's identity; but
- May supply the drug even if he/she is not satisfied as to the identity of that person.
- The new regulations do allow discretion not to ask patients or patient representatives for proof of identity if, for example, they have concerns that to do so may compromise patient confidentiality or deter patients from having their medicine dispensed.
Reporting Accidental Loss
In case of accidental loss of controlled substances due to spilling or breaking a container, use DEA Form.
Keeping and storage of Schedule 2 Controlled Drugs and buprenorphine
These CDs must be kept in a locked receptacle. This can be a doctor's bag with a lock and, if the bag is transported in the doctor's car, it must be locked and placed in a locked boot. A locked car is not adequate security; the bag must also be locked.
Requirements for records
Records for Schedule 2 CDs must be kept in a CD register. This is not a legal requirement for Schedule 3, 4 or 5 CDs.
All healthcare professionals who hold personal CD stock must keep their own CD register, and they are personally responsible for keeping this accurate and up-to-date.
The register must:
- Be bound (not loose-leaved) or a computerised system which is in accordance with best practice guidance.
- Contain class sections for each individual drug.
- Have the name of the drug specified at the top of each page.
- Have the entries in chronological order and made on the day of the transaction or the next day.
- Have the entries made in ink or otherwise so as to be indelible or in a computerised form in which every such entry is attributable and capable of being audited.
- Not have cancellations, obliterations or alterations; corrections must be made by a signed and dated entry in the margin or at the bottom of the page.
- Be kept at the premises to which it relates and be available for inspection at any time. A separate register must be kept for each set of premises (eg, at each branch surgery).
- Be kept for a minimum of two years after the date of the last entry, once completed.
- Not be used for any other purpose.
- For CDs received into stock, the following details must be recorded in the CD register:
- The date on which the CD was received.
- The name and address of the supplier - eg, wholesaler, pharmacy.
- The quantity received.
- The name, form and strength of the CD.
- For CDs supplied to patients (via prescriptions), or to practitioners (via requisitions), the following details must be recorded in the CD register:
- The date on which the supply was made.
- The name and address of the patient or practitioner receiving the CD.
- Particulars of the authority of the person who prescribed or ordered the CD.
- The quantity supplied.
- The name, form and strength in which the CD was supplied.
- The Secretary of State for Health can authorise the medical adviser of the CCG or other appointed doctor to ask GPs to produce records and to view stocks. Failure to comply is an offence.
Destroying Controlled Drugs
NB: professional guidance strongly recommends that any medication returned from patient stocks should not be re-issued or used to treat other patients.
- Make a record of the destruction in a separate book set aside for this purpose.
- When a CD is destroyed, details of the drug must be entered into the CD register. This should include: the name of the drug, form, strength and quantity, the date it was destroyed, and the signature of the authorised person who witnessed the destruction and that of the professional destroying it (i.e. two signatures).
- The list of those authorised to witness the destruction of CDs includes:
- A CCG chief pharmacist or pharmaceutical prescribing adviser who reports directly to the chief executive or to a director of the CCG.
- A registered medical practitioner who has been appointed to the CCG Professional Executive Committee or equivalent.
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